Product Quality – Designs By Janie http://designsbyjanie.com/ Wed, 22 Jun 2022 08:15:00 +0000 en-US hourly 1 https://wordpress.org/?v=5.9.3 https://designsbyjanie.com/wp-content/uploads/2021/06/icon-2-150x150.png Product Quality – Designs By Janie http://designsbyjanie.com/ 32 32 Samsung to announce mass production of 3nm chip next week: Report https://designsbyjanie.com/samsung-to-announce-mass-production-of-3nm-chip-next-week-report/ Wed, 22 Jun 2022 08:15:00 +0000 https://designsbyjanie.com/samsung-to-announce-mass-production-of-3nm-chip-next-week-report/ Samsung Electronics is expected to announce mass production of 3-nanometer semiconductors next week, sources said Wednesday, beating foundry rival TSMC in the advanced chipmaking process. The next-generation 3nm chips will be built on Gate-All-Around (GAA) technology, which Samsung says will enable up to 45% area reduction while delivering 30% better performance […]]]>


Samsung Electronics is expected to announce mass production of 3-nanometer semiconductors next week, sources said Wednesday, beating foundry rival TSMC in the advanced chipmaking process.

The next-generation 3nm chips will be built on Gate-All-Around (GAA) technology, which Samsung says will enable up to 45% area reduction while delivering 30% better performance and lower power consumption. 50% less, compared to the existing process.

The South Korean tech giant presented its 3nm chips to US President Joe Biden last month during his visit to Samsung’s semiconductor factory here, Yonhap news agency reports.

TSMC, the world’s largest contract chipmaker, said it would begin mass production of 3nm chips in the second half of the year.

The two companies have been in fierce competition to outdo each other in bringing the most advanced and efficient chips to the mass market and to win customers for contract chip manufacturing.

Samsung, the world’s largest memory chipmaker and second-largest foundry player, said its 2nm process node is in the early stages of development, with mass production planned for 2025.

According to industry tracker TrendForce, TSMC took 53.5% of the global foundry market, followed by Samsung with 16.3%, in the first quarter of this year.

In 2019, Samsung unveiled a massive $151 billion investment plan in the logic chip and foundry sectors by 2030, as the tech giant plans to expand its leadership beyond the sector. of memory.

–IANS

n / A/

(Only the title and image of this report may have been edited by Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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Charlotte’s Web appoints Greg Gould Chief Financial Officer and Chief Administrative Officer https://designsbyjanie.com/charlottes-web-appoints-greg-gould-chief-financial-officer-and-chief-administrative-officer/ Mon, 20 Jun 2022 20:15:00 +0000 https://designsbyjanie.com/charlottes-web-appoints-greg-gould-chief-financial-officer-and-chief-administrative-officer/ Greg Gould is a senior finance executive with over two decades of experience in CFO roles, leading multiple small to mid-sized companies in the natural wellness and biopharmaceutical industries. Mr. Gould brings significant financial and operational experience gained from publicly traded and private companies. He is a Certified Public Accountant with expertise in building and […]]]>

Greg Gould is a senior finance executive with over two decades of experience in CFO roles, leading multiple small to mid-sized companies in the natural wellness and biopharmaceutical industries. Mr. Gould brings significant financial and operational experience gained from publicly traded and private companies. He is a Certified Public Accountant with expertise in building and leading accounting departments, finance teams and reporting systems.

Mr. Gould has served as the Company’s financial advisor since April of this year, providing leadership and support for the Company’s financial and regulatory reporting process. Charlotte’s Web has become a registered reporting issuer with the U.S. Securities and Exchange Commission for 2022, and Mr. Gould has significant experience in senior financial roles for SEC-listed reporting companies.

“Through Greg’s advisory work with Charlotte’s Web this year, his knowledge of our business and our leadership allows for a smooth transition,” said Jacques Tortoroligeneral manager of Charlotte’s The Web. “And with his 20 years of experience in the natural wellness and biotech industries, his appointment is a key asset to our future business strategy.”

Mr. Gould said: “I am very happy to join the Charlotte’s The web team will continue to build the world’s leading CBD brand as we focus on the most effective way to improve the quality of life for people around the world while creating long-term shareholder value. »

Lindsey Jensenthe former Chief Financial Officer, resigned for personal convenience and will remain with the Company for a transitional period. The Board of Directors expresses its appreciation for the significant contributions Ms. Jensen has made to the Company since joining Charlotte’s Web in 2019 and wish him good luck in his future endeavours.

Subscribe at Charlotte’s The news of web investors.

About Charlotte’s Web Holdings, Inc.

Charlotte’s Web Holdings, Inc., a Certified B Corporation headquartered in denveris the market leader in innovative hemp extract-based wellness products under a family of brands that includes Charlotte’s Web™, CBD Medic™, CBD Clinic™ and Harmony Hemp™. Charlotte’s Premium Web-branded products begin with proprietary hemp genetics that are grown 100% on a US farm using organic and regenerative cultivation practices. The Company’s hemp extracts contain natural botanical compounds, including cannabidiol (“CBD”), CBC, CBG, terpenes, flavonoids and other beneficial compounds. The company’s CW Labs R&D division advances hemp science in two centers of excellence in Louisville, Coloradoand the Hauptmann Woodward Research Institute in University at Buffalopart of the State University of New York (SUNY) network. Web Product Categories Include Full Spectrum Hemp CBD oil tinctures (liquid products), CBD gummies (sleep, stress, exercise recovery)CBD capsules, Topical CBD creams and lotionsas good as CBD Pet Products for Dogs. Thanks to its vertically integrated business model, Charlotte’s Web maintains rigorous control over product quality and consistency with over 20 product batch tests for quality assurance. Charlotte’s Web products are distributed to more than 15,000 retailers, more than 8,000 healthcare professionals, and online through the company’s website at www.CharlottesWeb.com

Forward-looking information
Certain information contained in this press release constitutes forward-looking statements and forward-looking information within the meaning of applicable securities laws (collectively, “Forward-Looking Information”). In some, but not necessarily all, cases, forward-looking information may be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect to ‘, ‘is expected’, ‘opportunity exists’, ‘is positioned’, ‘estimates’, ‘intends’, ‘assumes’, ‘anticipates’ or ‘does not anticipate’ or ‘believes’, or variations of these words and phrases or states that certain actions, events or results “may”, “could”, “will”, “could”, “will” or “will be taken”, “will occur” or “will be carried out” . In addition, any statement that refers to expectations, projections or other characterizations of future events or circumstances contains forward-looking information. ‎Specifically, this press release contains forward-looking information regarding, among other things: the future of Charlotte’s Web and the impacts of management changes.

Statements containing forward-looking information are not historical facts, but rather represent management’s current expectations, estimates and projections regarding the future of our business, future plans, strategies, projections, expected events and trends, the economy and other future conditions. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates which, although considered reasonable by the Company as of the date of this press release, are subject to risks, uncertainties, assumptions and other known and unknown factors that may cause actual results, level of activity, performance or achievements to differ materially from those expressed or implied by such forward-looking information. Important factors and assumptions used in developing the forward-looking information contained herein include, but are not limited to, the following: the impact of the COVID-19 pandemic; the regulatory climate in which the Company currently operates and may operate in the future; consumer interest in CBD; successful sales of the Company’s products; and the success of sales and marketing activities. Important factors that could cause actual results and financial condition to differ materially from those set forth in the forward-looking information include, among others, the factors discussed in the “Risk Factors” section of the Company’s most recent annual report filed on Form 10-K. for the year ended December 31, 2021 Available on www.SEDAR.com and www.sec.gov and other risk factors contained in other documents filed with the Securities and Exchange Commission available at www.sec.gov and filings with Canadian securities regulators available at www.sedar.com. Except as required by applicable securities laws, the Company undertakes no obligation to update publicly any forward-looking information, whether written or oral, which may be made from time to time, whether as a result of new information, future developments or otherwise.

THE SOURCE Charlotte’s Web Holdings, Inc.

For further information: Cory Pala, Director of Investor Relations, (720) 484-8930, [email protected]

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Baby Diapers Market Size, Scope and Forecast https://designsbyjanie.com/baby-diapers-market-size-scope-and-forecast/ Sun, 19 Jun 2022 03:59:14 +0000 https://designsbyjanie.com/baby-diapers-market-size-scope-and-forecast/ New Jersey, United States – The baby diaper market The research report examines the market in detail over the predicted period. The research is divided into sections, each of which includes analysis of market trends and changes. Drivers, limitations, opportunities, and barriers, as well as the impact of numerous aspects on the industry, are all […]]]>

New Jersey, United States – The baby diaper market The research report examines the market in detail over the predicted period. The research is divided into sections, each of which includes analysis of market trends and changes. Drivers, limitations, opportunities, and barriers, as well as the impact of numerous aspects on the industry, are all variables of market dynamics.

The report provides participants with essential information as well as specific recommendations for gaining a competitive advantage in the global business world. It studies how different players compete in the global market and shows how they compete differently. Market size for Baby Diaper Market is calculated using a projected period included in the research study. Current market status and trends, along with business growth drivers, industry share, sales volume, interesting BI dashboards, and market forces are all explored.

Get Sample Full PDF Copy of Report: (Including Full TOC, List of Tables & Figures, Chart) @ https://www.verifiedmarketresearch.com/download-sample/?rid=129069

Key Players Mentioned in the Baby Diapers Market Research Report:

Bumkins Finer Baby Products Inc., Domtar Corporation, Essity Aktiebolag (PUBL), First Quality Enterprises Inc., Hengan International Group Company Limited, Kao Corporation, Kimberly-Clark Corporation, Ontex Group NV, The Procter & Gamble Company and Unicharm Corporation

Our analysts have performed a qualitative and quantitative analysis of the microeconomic and macroeconomic components of the Baby Diapers market. This study will also help to understand the changes in Baby Diapers market industrial supply chain, manufacturing processes and costs, sales scenarios and market dynamics.

This analysis highlights significant mergers and acquisitions, business expansion, differences in goods or services, market structure, competitive conditions in the Baby Diapers market, and market size by participant.

Baby Diaper Market Segmentation:

Baby Diapers Market, By Product

• Cloth layers
• Disposable diapers

Baby Diapers Market, By Size

• Small and very small (S and XS),
• Medium (M),
• Large (L) and extra large (XL)

Baby Diaper Market, By Age Group

• Infants (0 to 6 months)
• Babies and young toddlers (6 to 18 months)
• Toddlers (18 – 24 months)
• Children over 2 years old

Baby Diaper Market, By Distribution Channel

• Hypermarket/Supermarket
• Convenience stores
• Pharmacy/drugs
• Online sales channel
• Others

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Scope of Baby Diapers Market Report

ATTRIBUTES DETAILS
ESTIMATED YEAR 2022
YEAR OF REFERENCE 2021
FORECAST YEAR 2029
HISTORICAL YEAR 2020
UNITY Value (million USD/billion)
SECTORS COVERED Types, applications, end users, and more.
REPORT COVER Revenue Forecast, Business Ranking, Competitive Landscape, Growth Factors and Trends
BY REGION North America, Europe, Asia-Pacific, Latin America, Middle East and Africa
CUSTOMIZATION SCOPE Free report customization (equivalent to up to 4 analyst business days) with purchase. Added or changed country, region and segment scope.

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5. Which regional market will show the strongest growth?

6. What will be the CAGR and size of the Baby Diapers market throughout the forecast period?

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New national poll shows most consumers confused about safety and quality standards for cannabis products https://designsbyjanie.com/new-national-poll-shows-most-consumers-confused-about-safety-and-quality-standards-for-cannabis-products/ Wed, 15 Jun 2022 14:06:56 +0000 https://designsbyjanie.com/new-national-poll-shows-most-consumers-confused-about-safety-and-quality-standards-for-cannabis-products/ New National Study Reveals Consumer Confusion around US standards for the safety and quality of cannabis productsshowing that there is a widely held and inaccurate assumption that cannabis products enjoy the same basic protections that exist for food, pharmaceutical and personal care products in the United States. The national survey was conducted online by The […]]]>

New National Study Reveals Consumer Confusion around US standards for the safety and quality of cannabis productsshowing that there is a widely held and inaccurate assumption that cannabis products enjoy the same basic protections that exist for food, pharmaceutical and personal care products in the United States.

The national survey was conducted online by The Harris Poll behalf SICPAone of the leading providers of regulatory compliance solutions, and the Unified Cannabis Standards Foundation (FOCUS) among more than 2,000 American adults. Results include:

  • Almost three quarters of Americans overall (72%) and 80% of American cannabis consumers believe that cannabis products are grown and produced under consistent product safety standards (regardless of the state in which they are legally purchased).

  • More … than four out of five Americans globally (81%) and 84% cannabis consumers believe that no matter where they are located, businesses licensed to grow and produce cannabis products must meet consistent environmental standards.

  • More … than three-quarters of Americans in general (77%) and 81% of cannabis users, believe that cannabis employers are held to the same health and safety standards for their workers as all other industries.

“Our new survey shows that Americans are grossly misinformed about the lack of basic safety and quality protections for cannabis products in many states,” said Karen Gardner, Marketing Director, SICPA US. “Even cannabis users themselves don’t know that in states where the products are legal, there are no uniform standards, which leaves a lot of room for unsafe, low-quality products on the market. “

The SICPA-Harris poll also probed sentiments regarding support for the federal government to set standards for cannabis products. An overwhelming majority of 84% of Americans overall and 84% of cannabis consumers support the establishment of federal standards for the safety and quality of cannabis products produced or sold in the United States. Similarly, 83% of Americans overall and 83% of cannabis users support the federal government setting standards. for environmental protections that must be adhered to by the US cannabis industry in the United States

The poll showed that broad support among Americans also exists for the decriminalization and/or legalization of cannabis products. Nearly three in four Americans (74%) overall and almost four in five cannabis users (79%) support decriminalization and more than three in four Americans (78%) and a large majority (86% ) of cannabis users support legalization. cannabis nationally.

The SICPA-Harris Poll survey also measured cannabis use among Americans, revealing that 55% of Americans have used cannabis products at some point, with more than two in five (42%) reporting having used cannabis. cannabis products in the past 12 months. , and 16% reporting having used cannabis products for the first time in the last 12 months.

This is the third SICPA-The Harris Poll on cannabis; in February, the second survey showed overwhelming support among cannabis consumers for more in-depth information about the products they use. The first poll, published last fall, showed broad support among Americans for the secure labeling of cannabis products to verify their legitimacy and safety in the marketplace.

picture by Distribution of thousands via Shutterstock

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Back to the drawing board for FDA’s revised quality metrics plan? https://designsbyjanie.com/back-to-the-drawing-board-for-fdas-revised-quality-metrics-plan/ Mon, 13 Jun 2022 21:18:30 +0000 https://designsbyjanie.com/back-to-the-drawing-board-for-fdas-revised-quality-metrics-plan/ The U.S. Food and Drug Administration’s (FDA) revised plan to collect quality measurement data from manufacturers has drawn criticism from a major pharmaceutical industry group over the measures proposed by the agency, as well as its methods of program development. Others complained about the lack of focus of the proposed program, while two industry groups […]]]>

The U.S. Food and Drug Administration’s (FDA) revised plan to collect quality measurement data from manufacturers has drawn criticism from a major pharmaceutical industry group over the measures proposed by the agency, as well as its methods of program development. Others complained about the lack of focus of the proposed program, while two industry groups also expressed serious reservations about the aim of the program as a whole.

Still, on a positive note, an industry group and a major manufacturer praised the plan’s flexibility in allowing manufacturers to decide which metrics to report.

The FDA issued calls for comment when it released its revised quality metrics proposal in March. (RELATED: Quality Indicators: FDA Seeks Feedback on Streamlined ProgramRegulatory guidance March 8, 2022)

The proposal is the FDA’s attempt to revive its previously stalled efforts to obtain manufacturing quality data to reduce potential drug shortages. Feedback was a bit more supportive of this blueprint’s flexibility compared to previous iterations. (RELATED: Industry wants FDA to rein in quality metrics program, Regulatory guidance March 30, 2017).

The agency stressed in an announcement that this program would be different from the original draft guidance on quality measures unveiled in 2015, as well as the revised draft guidance released in 2016.

The FDA has identified four areas, with individual metrics within each of the areas, as appropriate for reporting: manufacturing process performance, pharmaceutical quality system (PQS) effectiveness, laboratory performance, and supply chain robustness. The reporting facility would select the most appropriate metrics in each practice area and notify FDA how they were calculated. The FDA has also sought comment on whether facility-level reporting is appropriate.

Leased flexibility

Pfizer and the Parenteral Drug Association (PDA) supported the flexibility of the proposed quality metrics program.

Pfizer said: “In principle, we agree with the proposed direction of the FDA QM reporting program and the flexibility on what metrics are reported, as well as the ability for each estimate to be able to define how the metrics are calculated. .”

Still, Pfizer noted that “the program introduces potential ‘incentives’ but does not address specific regulatory and supervisory incentives, such as possible reduced inspection frequency.”

PDA also supported the flexibility of the proposal. The group writes that “enabling a site to select those metrics within a specified practice area that are most appropriate to their operations and best characterizes their site’s maturity or opportunity for improvement is a positive development for the industry”.

PSI calls for increased engagement

In its comments, the International Society for Pharmaceutical Engineering (ISPE) said the FDA needs to seek more outside engagement from industry to develop the program.

“The current approach of issuing guidelines, piloting programs, commenting on case requests, and responding to surveys at FDA conferences provides limited opportunities for dialogue. The expertise that all parties could provide to develop this important initiative could be better harnessed,” PSI wrote.

In addition, the group said its members do not support any of the four practice areas suggested by the FDA.

For example, members told PSI that supply chain robustness “may be relevant to the business performance of some companies, however, there was not a high level of support for these measures in our survey with many strong comments that they were beyond the scope of a quality metrics reporting program.

Bristol-Meyers Squibb also expressed concern about including supply chain strength as an indicator. “BMS is concerned about the inclusion of the Supply Chain General Practice Area because it may be redundant or duplicate other initiatives such as the CARES Act volume reporting requirement.”

The ISPE also said its members were “biased” on the FDA’s recommendation to report process capability values, and therefore, “cannot recommend inclusion of this metric.”

The group said the number of batches manufactured during a reporting period “may be insufficient to support the calculation of process performance as well as the variable and inconsistent definition of specification acceptance criteria”.

In addition, the ISPE stated that the PQS measure of effectiveness was not supported by its members. ISPE also recommends moving the performance metric from the lab to the manufacturing process performance domain and removing the invalidated/reversed out of specification (IOOSR) metric from the list of potential metrics.

AAM and PBOA have serious doubts

Two groups, the Association for Accessible Medicines (AAM) and the Pharma & Biopharma Outsourcing Association (PBOA), a trade association representing contract manufacturers, have expressed reservations about the program.

The AAM said the FDA proposals are not aligned with the group’s proposal outlining five principles for reporting key quality measures in a 2021 while the paper. These principles include the following: quality measures must be within the boundaries of clear statutory authority, quality measures data must be collectable and participation must be feasible, quality measures must be formalized by product types and product risk and quality measures should not create “perverse” incentives. .

The AAM wrote that the FDA’s proposed quality metrics program is not aligned with any of these principles and “in many respects it departs even further from them than some of the previous Quality Metrics Reporting Program proposals.” FDA quality measures”.

The group adds, “We are concerned that potential new guidance proposed by the FDA for a quality metrics reporting program still lacks appropriate legal authority, may incorporate metrics that have not been validated, and may not be relevant to quality, and would encourage the submission of metrics that do not make sense and would not advance public health.

Along the same lines, the PBOA complained about the lack of focus in the FDA’s proposal and recommends that the agency “better define its purpose and the intent behind this initiative.”

“Without collecting data in a targeted manner and with a clear purpose, our members are concerned about how these metrics will be interpreted and how they may incorrectly reflect quality maturity status or direction. The PBOA is also concerned that the metrics collected will vary significantly depending on the metrics of the site relative to the products, the development status of the drugs being measured, the annual manufacturing demand, and the age of the product/ manufacturing process.

The group also wrote that “there is no clear and positive incentive for CDMOs to participate in the program, only negative incentives. Incentives that the FDA has cited in the past have been discussed and focus on sponsor/MAH goals. »

Supported establishment site metrics

In other areas, BMS said it supports the inclusion of settlement site metrics. The use of these metrics “will allow the reporting of meaningful metrics for the operations of the institution. Measures should be selected to enable an institution to monitor its own operations and drive continuous improvement.

BMS also recommended that the agency take a phased approach to rolling out the program.

Organic products are not sufficiently taken into account

In terms of specific products covered by the plan, the Biosimilars Council said the quality measurement program is not suitable for manufacturers of biologics.

The proposal does not “sufficiently take into account the inherent differences between specific product categories (ie, biologics versus chemically synthesized small molecule pharmaceuticals). Particularly due to the complexity of biological products, it would be inappropriate to compare the metric data of one biological site to other incomparable sites, such as that of a simple oral solid. For example, bioassays can have high invalid rates compared to a typical analytical method of high performance liquid chromatography (HPLC).

The board said, “Because the FDA intends to use quality measurement data to develop compliance and inspection policies and practices, biologics could be subject to treatment. unfair if these differences between product categories are not taken into account. Therefore, manufacturers of biosimilars can choose not to participate in the program.

Comments on quality indicators

© 2022 Society of Regulatory Affairs Professionals.

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IWK pediatricians create app for teens to recognize their heavy periods https://designsbyjanie.com/iwk-pediatricians-create-app-for-teens-to-recognize-their-heavy-periods/ Sat, 11 Jun 2022 15:00:15 +0000 https://designsbyjanie.com/iwk-pediatricians-create-app-for-teens-to-recognize-their-heavy-periods/ After noticing that many teens were skipping school activities because of their periods, a group of pediatricians at the IWK Health Center wanted to make sure teens got the help they needed. “We’re really trying to increase communication and education about periods to reduce the stigma around periods and to discuss them,” pediatrician Megan Pike […]]]>

After noticing that many teens were skipping school activities because of their periods, a group of pediatricians at the IWK Health Center wanted to make sure teens got the help they needed.

“We’re really trying to increase communication and education about periods to reduce the stigma around periods and to discuss them,” pediatrician Megan Pike told CBC Radio. Main Street Friday.

Pike is one of the leaders behind the WeThrive app. She spoke to guest host Carolyn Ray about how the new app designed specifically for teens is inclusive and helps break down communication barriers when help is needed.

This conversation has been edited for clarity and length.

What makes it different from other period tracking apps out there today?

I really wanted this app to be exclusively designed for teenage girls focusing only on menstruation without any information on ovulation, fertility or intimacy. And so the application is only for menstruation. It was designed exclusively by pediatricians, myself and Dr. Price.

My work has mostly focused on teenage girls with bleeding disorders because, as you can imagine, many of them have heavy menstrual bleeding, but that’s just one of many causes of heavy periods and Just because a person has a heavy period doesn’t necessarily mean they have a bleeding disorder, but it is one of the signs of a bleeding disorder.

I hope with this app I can help teens recognize their heavy bleeding to aid clinicians and the early identification and management of bleeding disorders.

It is also gender neutral in its color and theme. I really wanted anyone on their period to feel comfortable with the app and regardless of their identified gender and most other period tracker apps use a lot of female language. And so I tried to avoid that.

So tell me more about this app. If she and a young adult tune into it and begin to see that their situation may be abnormal. What happens?

The app can recognize heavy menstrual bleeding in two ways.

The first is to use menstrual tracking so that a user can track the number of products they have used in a period. So, menstrual pads, tampons, and cups as well as their saturation level to know how full they look every time they change product during their period.

The app is set to be appealing to teenage girls so they can do so by simply touching the emoticons on the screen for each day of their period to help track how many products they have used at the end of their period. rules.

The app will generate a score. We call it the Pictorial Bleeding Assessment Score. But on the app, it is only a period score, and a score above 100 can be identified as heavy menstrual bleeding, so it is a way.

The other way is to embed this quality of life questionnaire that I posted in the app and so if a teenage girl doesn’t want to track or isn’t comfortable with menstrual tracking, she can answer 20 questions about the impact of her periods on their quality of life, and this will also score them with a score above 30 indicating possible heavy menstrual bleeding.

If the app identifies heavy bleeding, there is a list of clinics that I actively update all the time of healthcare providers who can see patients with heavy menstrual bleeding.

Does it require any personal information?

No.

When a user first downloads the app, they are asked whether or not they want their anonymized rule tracking data used in research so that I can access their anonymized rule tracking scores and scores on the Quality of Life Questionnaire to better understand the impact of menstrual bleeding on adolescent girls.

This is optional if users choose to participate in research. All I see is their age and the score they get from their menstrual tracker.

And Dr. Pike, do you hope that makes young people more comfortable talking about their periods and things like that?

We are really trying to increase communication and education about periods with the goal of reducing the stigma around and discussing periods. So hopefully we will thrive as an app as well as our social media presence will help reduce the stigma around discussions about menstruation, especially for teens.

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Marks Eyes Gene Therapy Development Pilot, Sees Increase in Successful RMAT Applications https://designsbyjanie.com/marks-eyes-gene-therapy-development-pilot-sees-increase-in-successful-rmat-applications/ Thu, 09 Jun 2022 20:35:41 +0000 https://designsbyjanie.com/marks-eyes-gene-therapy-development-pilot-sees-increase-in-successful-rmat-applications/ Posted on June 09, 2022 | By Joanne S. Eglovitch FDA’s Peter Marks Peter Marks, director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), attributes an increase in the number of advanced regenerative medicine (RMAT) therapy applications approved for cell therapies and genes to sponsors the blow” of […]]]>

Posted on June 09, 2022 | By Joanne S. Eglovitch

FDA’s Peter Marks

Peter Marks, director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), attributes an increase in the number of advanced regenerative medicine (RMAT) therapy applications approved for cell therapies and genes to sponsors the blow” of the agency’s expectations for nomination requests.

Marks spoke at the California Separation Science Society (CASSS) June 8 meeting on cell and gene therapies. The meeting took place both in person in Arlington, VA and virtually.

Marks also expressed interest in starting a pilot gene therapy program where sponsors would get real-time feedback from FDA reviewers on their development programs. The pilot would test which approaches work best and which don’t in developing these products. This would help avoid setting regulatory policies for approaches that are not practical.

Slight increase in RMAT acceptance

The RMAT program was created by the 21st Cures of the Century Act in 2016 to accelerate the development and approval of products of cell and genetic theories. To qualify for the RMAT designation, products must be intended to treat serious or life-threatening diseases or conditions, and preliminary evidence must indicate the treatment’s potential to address unmet medical needs. The FDA will respond to designation requests within 60 days. Designated products are also eligible for priority review and expedited approval.

As of March 31, 2022, CBER has received more than 180 designation requests, granted 38% of those requests, and denied 56% of them. A small number of applications have been withdrawn or are currently pending.

Marks said that “one of the interesting trends we are seeing is a slight increase in the number of applications we are able to grant compared to the number of nominations submitted. People seem to understand better what we are looking for, I hope this trend continues.

He added that many of these designations relate to cell therapies, while “some” relate to gene therapies. About half of the RMATs relate to rare diseases, and a number of them relate to rare diseases with an orphan product designation.

Marks said the reason for the rejections had “changed over time” when asked to address the reasons for the rejections at the meeting. The most common reason is that the data generated by the trials do not show a clear treatment difference between patients who were treated with the therapy and those who were not.

“The most common reason for refusal is not because the product is not going to treat the serious disease. The problem is that the data generated is often very difficult to see that there is a clear difference between the few patients who have been processed and those that have not.

Brands interested in the gene therapy pilot program

Marks also expressed interest in establishing a gene therapy product development program in which the FDA would work with sponsors developing these therapies to provide “real-time feedback” on their programs. He said this type of feedback and interaction would be similar to Operation Warp Speed, a federal initiative to accelerate the development and production of COVID-19 vaccines, therapies and diagnostics.

During a Q&A at the end of the panel, Marks said the pilot will aim to address agency capacity issues and shed early light on what approaches are working and what isn’t working beforehand. that the FDA does not implement regulatory processes.

“My reason here for trying to do pilot projects is that no, we don’t have the resources right now to offer the kind of individual services that we would like to be able to do.” Yet the pilot would “show Congress that” yes, we did this pilot and in X number of cases we were able to speed up the development of this product by X percent. “With this pilot, he added, the FDA would be able to “excite Congress about what’s possible if you’re able to have these types of interactions.

CASS meeting

© 2022 Society of Regulatory Affairs Professionals.


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Researchers hope to develop rapid pathogen tests for poultry https://designsbyjanie.com/researchers-hope-to-develop-rapid-pathogen-tests-for-poultry/ Wed, 08 Jun 2022 04:34:21 +0000 https://designsbyjanie.com/researchers-hope-to-develop-rapid-pathogen-tests-for-poultry/ Michigan State University researchers are working on a rapid cellphone test method to detect bacteria on poultry that cause human illnesses such as Salmonella and Campylobacter infections. Led by Evangelyn Alocilja, a professor in the Department of Biosystems and Agricultural Engineering at MSU, the research team’s work is supported by a grant from the Food […]]]>

Michigan State University researchers are working on a rapid cellphone test method to detect bacteria on poultry that cause human illnesses such as Salmonella and Campylobacter infections.

Led by Evangelyn Alocilja, a professor in the Department of Biosystems and Agricultural Engineering at MSU, the research team’s work is supported by a grant from the Food Research Initiative of the National Institute of Food and Agriculture. of USDA Agriculture. The grant is $769,000.

Alocilja said if researchers can fix problems before products leave farms and processors, it would go a long way to improving food safety.

The researcher said previous studies have shown that poultry products are one of the most common sources of human infection due to bacterial contamination from agricultural production practices and processing equipment.

According to the USDA’s Economic Research Service, the US economic burden of Salmonella and Campylobacter from all sources exceeded $6 billion in 2018.

According to Alocilja, it currently takes days or even weeks for culture tests to identify bacteria on poultry, and some modern rapid tests are extremely expensive and require training. The goal, she said, is to create rapid tests that are inexpensive and accessible, and easy enough to use for people in many different industries to implement.

Alocilja, whose work is also supported by MSU AgBioResearch, is a world-renowned expert in rapid biosensing diagnostics of infectious and antimicrobial-resistant diseases, having developed such tests for tuberculosis, dengue and COVID-19.

The project is a partnership between MSU and Tuskegee University. Tuskegee’s contributions will be led by Woubit Abebe, a collaborator on previous projects with Alocilja. She is a professor and director of the Tuskegee Center for Food Animal Health and Food Safety.

Other members of the MSU team include Jeannine Schweihofer, senior meat quality educator with MSU Extension; Tina Conklin, food processing specialist at MSU Product Center; Erica Rogers, environmental extension educator with MSU Extension; and Zac Williams, Poultry Outreach Specialist in the Department of Animal Science.

For this project, the team’s goals are to optimize Alocilja’s existing biosensor technologies for Salmonella and Campylobacter, develop a mobile phone-based application that captures and analyzes test data, and validate the process in several poultry farms and processing facilities.

Preliminary results showed that the biosensor was able to detect genomic DNA from foodborne pathogens in approximately one hour.

“We want to make sure food is safe while helping processors get their products into the hands of consumers quickly,” Alocilja said.

Alocilja plans to use her role as founder of the Global Alliance for Rapid Diagnostics to reach colleagues around the world with information about the research project.

The project is a partnership between MSU and Tuskegee University. Tuskegee’s contributions will be led by Woubit Abebe, a collaborator on previous projects with Alocilja. She is a professor and director of the Tuskegee Center for Food Animal Health and Food Safety. Alocilja said his engineering expertise combined with Abebe’s experience in veterinary medicine forms a unique partnership focused on human health and food safety.

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Unscrupulous ivory traders can escape new UK ban, charity says | Animal wellbeing https://designsbyjanie.com/unscrupulous-ivory-traders-can-escape-new-uk-ban-charity-says-animal-wellbeing/ Mon, 06 Jun 2022 05:00:00 +0000 https://designsbyjanie.com/unscrupulous-ivory-traders-can-escape-new-uk-ban-charity-says-animal-wellbeing/ Ivory dealers could continue to sell elephant tusks after a new ban by disguising their products as walrus or narwhal derivatives, campaigners have warned. As of Monday, the trade in elephant teeth and tusks has been illegal in the UK, punishable by fines of up to £250,000 or five years in prison under the Ivory […]]]>

Ivory dealers could continue to sell elephant tusks after a new ban by disguising their products as walrus or narwhal derivatives, campaigners have warned.

As of Monday, the trade in elephant teeth and tusks has been illegal in the UK, punishable by fines of up to £250,000 or five years in prison under the Ivory Act. Musical instruments from before 1975 and ancient objects of “exceptional importance” are exempt from the law, as well as ivory from species other than elephants.

But Born Free Foundation, a wildlife charity, is calling for the ban to be extended to ivory from other species, saying unscrupulous sellers could otherwise pass off elephant products as derivatives of unprotected mammals.

Research by the campaign group found £1.1million worth of ivory-containing products offered for sale on three UK online marketplaces in a single month at the end of 2021. In two-thirds of the 1,832 listings of ivory products, it was impossible to identify the species because of the limited number and quality of images provided, the researchers said.

Among the objects containing ivory where the species could be identified, the majority came from elephants (491 out of 606), with walruses (48), sperm whales (26), hippos (15), warthogs (12), mammoths (eight) and narwhals (six) were also featured.

Will Travers OBE, co-founder and executive chairman of Born Free, said: “The take-home message from our report is that all trade in ivory – regardless of species – must end. Just a few weeks ago, wildlife law enforcement officials in the Democratic Republic of Congo intercepted 2,000 kg of ivory, which amounts to around 150 dead elephants.

“Through e-commerce, could this have been aimed – at least in part – at the UK market?”

Dr Mark Jones, Policy Officer of Born Free, said: “The government must now ensure that the system it has put in place to prevent the trade in most elephant ivory is sufficiently robust to ensure that only items that genuinely meet the exemption criteria can be marketed. Our research demonstrates the extent of the online ivory trade in the UK.

Jones said he fears law enforcement will find themselves stretched too thin to police the vast online market, allowing night dealers to pass off illegal elephant ivory as something else.

The Born Free report, titled Are Ivory Sellers Lying Through Their Teeth?, uncovered 331 cases in a single month of sellers selling ivory on eBay UK – despite ivory trading being banned on the platform in 2009 .

Most of the ivory products listed on the website were more or less subtly disguised, with an advertisement saying the item was “cold to the touch”, a recognized code phrase, and another saying the material was from “d ‘an animal with a trunk’.

Typically, sellers list products as ‘ivory’ or ‘faux ivory’ on eBay UK, while admitting they actually contained ivory in adverts for the same item appearing on specialist auction websites.

There were 414 individual sellers of ivory products across the UK and the Channel Islands identified during the month-long study period, selling products including walking sticks, ornaments, jewelery and a hair brush.

In addition to eBay, Born Free found items for sale on Barnebys (a popular search engine for auctioneers and antiques) and Antiques Atlas (a specialist online marketplace).

An eBay spokesperson said: “eBay is a founding member of the Coalition to End Online Wildlife Trafficking. We have worked to combat the illegal trade in elephant ivory for many years and work alongside WWF and IFAW to continually update our policies and processes. We have dedicated global teams to enforce our policies, and over a recent two-year period, we blocked or removed over 265,000 ads prohibited under our Animal Products Policy.

Antiques Atlas has since removed the ad in question. Iain Smith of Antiques Atlas said: “The ivory category and its associated stock has now been removed. We are not a large auction site with large volumes of stock sold weekly. We have had one article uploaded to this category within the last six months.

“Over the past two years we have seen that most dealers have reduced their stock of ivory and moved away from it…I don’t think I have come across a single antique dealer who was not against the illegal trade ivory and the threat it poses to this endangered species.Smith said he would also support a complete ban on the overseas sale of ivory from the UK.

The government requested evidence on the 2019 non-elephant ivory trade ban. Species considered for protection included hippos, killer whales, narwhals, sperm whales, walruses, common warthogs, desert warthogs and mammoths.

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A number of respondents to the consultation opposed extending the ivory ban to species other than elephants, with one saying it would have a hugely detrimental effect on musicians who rely on these sources for the manufacture and repair of instruments.

Another respondent argued that banning trade in ivory of these species would harm “small businesses, private collectors, museums, researchers and students of everything from antiques to antique ladies’ dresses, without preserving endangered animals.

Peter Goldsmith, Animal Welfare Minister, said: “The coming into force of the world-leading Ivory Law represents a historic moment in ensuring the survival of elephants around the world for future generations. Thousands of elephants are needlessly and cruelly targeted each year for their ivory for financial gain. As one of the toughest bans of its kind, we send a clear message that the trade in elephant ivory is totally unacceptable.

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The blame game for infant formula https://designsbyjanie.com/the-blame-game-for-infant-formula/ Sat, 04 Jun 2022 12:00:00 +0000 https://designsbyjanie.com/the-blame-game-for-infant-formula/ There’s a lot to blame about the shortage of infant formula plaguing the United States. It could be directed to the company where production was shut down, the Food and Drug Administration (FDA), or Congress. It probably starts with the FDA for discouraging competition and market resilience. Nevertheless, let’s start with the company. By now […]]]>

There’s a lot to blame about the shortage of infant formula plaguing the United States. It could be directed to the company where production was shut down, the Food and Drug Administration (FDA), or Congress. It probably starts with the FDA for discouraging competition and market resilience.

Nevertheless, let’s start with the company. By now anyone preparing food should know that the first thing to do is to keep your plant clean. FDA inspections revealed that food contact surfaces at the Abbott Laboratories Michigan plant were not clean. It does not mean that the product has harmed babies, which is determined more scientifically. Apparently the retained Abbott formula tested negative for Cronobacter sakazakii and Salmonella newport. Some Cronobacter sakazakii have been found in the plant, although the genetic sequences are different from those of diseased infants. There was other results and accusations which will receive all due attention.

But we have to remove the lens and look at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). FDA officials have sometimes tacitly admitted to a poor management structure. In the 1990s, Mike Taylor was brought in to manage nutrition labeling rules in the commissioner’s office. Apparently, the commissioner did not trust the director of the CFSAN to deal with it. Taylor returned in 2010 as deputy commissioner for food policy and response, a new position in place since.

But what exactly is a director supposed to do if there is a similar role in the commissioner’s office? In fact, when the FDA was supposed to investigate Abbott, current deputy food policy and response commissioner Frank Yiannis complained that he hadn’t heard of the whistleblower’s report before four months later. Neither the employees of the CFSAN office nor the field inspectors report to him. While having two leaders is a problem, it’s not the FDA’s biggest problem.

As I pointed out in “Fix foodwhen I was working on an FDA rule for infant formula in the late 1980s, I asked a senior regulator why there were only six companies making infant formula. He said companies regularly ask what they need to do to enter the formula market and comply with regulations. They were apparently told, in one form or another, that the FDA preferred that they not do it. Congress should request such documentation.

With fewer companies, FDA inspectors had fewer factories to cover. This becomes a big problem when a company with 40 percent of the share market is closed.

I found another problem at the time: our bylaws didn’t seem to address the issues we were having and for which we already had enough authority. Instead, the proposed rules added a lot of costly testing and record keeping. The costs of these requirements would naturally be passed on to consumers. And even parents who are entitled to reduced costs thanks to the special supplementary nutrition program for women, infants and children (WIC) program does not necessarily include. Only 49 to 56 percent actually register.

When prices go up, some people try to make formula last longer by adding more water. A study in clinical pediatrics found that 25 percent of food-insecure families admitted to considering ways to expand their formula. Adding too much water can results in too few calories, convulsions due to lack of salt and nausea, vomiting and diarrhea.

I recently checked if anything had changed in 35 years, and again found only six American formula companies. The FDA does not allow imports of infant formula, even from Canada. I was also somewhat surprised to see that during COVID-19 FDA food inspectors were working from home, among other things, recording evaluation. Why, if factories were fully staffed to make food products (including infant formula), was it safe for workers, but not for FDA inspectors?

The agency justified the decision by saying, “[I]Inspections don’t make quality happen. Safety and quality must belong to the industry, and companies have the primary responsibility to reliably produce quality products. If this is true, why is the FDA sticking to its old approaches and interrogate for more money for inspectors?

This brings us to the third leg of accountability: Congress. Recently, William Yeatman of the Cato Institute Noted:

“Agencies routinely submit nonsensical budget justifications intended to obscure administrative policy-making priorities, and lawmakers don’t bat an eyelid. Where once agencies rushed to respond to requests for information from committee heads, agencies today feign the semblance of questions from Congress, and lawmakers do nothing.

It’s Congress’s statutory duty to hold agencies accountable for results, and yet every year the FDA submits budget requests with little mention of actual successes or failures, like making food safer. And despite budgets that increase over the years, food is not safer. Lawmakers who are outraged today didn’t seem to notice.

It’s a nasty blame game, but the least we can do is distribute the blame fairly.

Richard Williams is a senior researcher affiliated with the Mercat Center at George Mason University and former Director of Social Sciences at the Food and Drug Administration’s Center for Food Safety and Applied Nutrition.

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