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Read important industry news with the latest articles on life sciences, manufacturing, and regulatory issues. 




2020 at FDA: A Year of Unparalleled Contributions to Public Health

It has been a year like no other in recent memory for public health. At the U.S. Food and Drug Administration, much of our focus has been dominated by our response to the COVID-19 pandemic. We’ve continued to make important scientific progress, with each day bringing new knowledge and understanding of the SARS-CoV-2 virus and the disease it causes, leading to the issuance of Emergency Use Authorizations (EUA) for two vaccines, and to increased availability of testing and treatment options.  The efforts by FDA staff in response to the virus involved a significant increase in the agency’s workload. But throughout, our workforce continued to make unparalleled contributions and demonstrated unwavering commitment to our many essential public health responsibilities.



Medical device approvals: FDA takes a STeP in the right direction

“The US Food and Drug Administration (FDA) has finally published the details of its new Safer Technologies Program (STeP) for medical devices, which aims to expedite approval for products with significant safety benefits that aren’t eligible for its Breakthrough Devices Program. Medical Device Network takes a look at what the new rules mean for manufacturers. The US Food and Drug Administration (FDA) released final guidance last week about its new, voluntary Safer Technologies Program (STeP). Modelled after the Breakthrough Devices Program, STeP is targeted at medical devices and device-led combo products seeking premarket approval (PMA), 501(k) premarket notification or a De Novo classification request.”



FDA lays out 2021 regulatory science areas of focus

“Three strategic initiatives form the backbone of the regulatory science areas of focus for the US Food and Drug Administration in 2021, according to a new report. The Focus Areas of Regulatory Science (FARS) issued on Monday “outlines topics that the FDA has identified as needing continued targeted investment in regulatory science research to facilitate the development of innovative products, provide data and methodology to inform regulatory decision-making and improve guidance to sponsors,” according to FDA Chief Scientist Denise Hinton.”


Quality Event Management

FDA veteran Woodcock takes over as acting commissioner in Biden administration

Just hours after U.S. President Joe Biden was inaugurated, Janet Woodcock, M.D., officially took the reins at the FDA. She will service as acting commissioner in an anticipated appointment, taking over for Stephen Hahn, M.D., whose one-year tenure was marred by the COVID-19 pandemic and claims of political gamesmanship. Woodcock is a veteran at the FDA, heading the Center for Drug Evaluation and Research since 2008 and previously from 1994 to 2005, for a total 23 years as director. She served in the FDA commissioner’s office from 2005 until 2008 in several roles, including deputy commissioner, chief medical officer and chief operating officer. She most recently worked as part of Operation Warp Speed, overseeing COVID-19 therapy development.



5 questions facing the FDA in 2021

“Few government agencies were as front and center in the public eye last year as the Food and Drug Administration, which came under immense pressure to authorize unproven drugs as the world grappled with the pandemic and conducted high-stakes reviews of two coronavirus vaccines. As COVID-19 cases continue to soar in the U.S., most of those pressures haven’t gone away. But the inauguration next week of Joseph Biden as president will almost certainly bring new management to the agency, a change that can often result in policy shifts both subtle and far-reaching.”





FDA finalizes feedback processes for combo products

“Developers of combination products have new final guidance from the US Food and Drug Administration about requesting feedback from the agency during the full product development cycle. In response to feedback received during the consultation period on the January 2020 draft guidance, FDA has adjusted the final guidance to give developers more information about the best use of combination product agreement meetings (CPAMs) as well as how agreements reached through CPAMs are structured and what they contain. The guidance is issued as part of 21st Century Cures Act mandates that require FDA to provide sponsors of combination products with final guidance that addresses how structured pre-submission interactions occur, best practices in pre-submission interactions to ensure getting FDA’s best advice, and how CPAMS fit in with other meeting types and what information is needed for CPAM requests.



How key decisions slowed FDA’s review of a Covid-19 vaccine — but also gave it important data

In September, as Pfizer and partner BioNTech were quickly advancing a study of their Covid-19 vaccine, dozens of well-known academics sent an open letter to Pfizer’s CEO with a simple plea: Please slow down and collect more data. It was not until Nov. 20 that the data were submitted to the Food and Drug Administration. Now, as the FDA prepares to convene a group of outside advisers on Thursday to review the data, and recommend whether the vaccine should be broadly used, many experts are voicing the opposite opinion. What, they ask, is taking so long? 



The Increasing Use Of AI In The Pharmaceutical Industry

“The pharmaceutical industry has long relied on cutting edge technologies to help deliver safe, reliable drugs to market. With the recent pandemic, it’s proved more important than ever for pharmaceutical companies to get drugs and vaccines to market faster than ever before. Artificial intelligence and machine learning have been playing a critical role in the pharmaceutical industry and consumer healthcare business. From augmented intelligence applications such as disease identification and diagnosis, helping identify patients for clinical trials, drug manufacturing, and predictive forecasting, these technologies have proven critical. 



UK shares post-Brexit device guidance as uncertainty around EU split looms

“The transition period that has kept the U.K. subject to EU law in recent months is set to stop at the end of the year. With three weeks to go, many details of what happens after that remain unclear due to the continuing inability of the two sides to reach agreement on some points, notably the extent to which the U.K. should be required to harmonize its standards with those of the EU. Medical device manufacturers that move components and products across borders between the EU and U.K. will be affected by the trade deal, or lack thereof, but are still waiting for information on the situation they will face in the new year.”




Ingredients, innovation and a need for speed: what’s in store for 2021

 By Jenni Spinner

Three leaders from pharma ingredients and innovation firm Lonza share views on challenges and opportunities likely to face the industry in coming months.




Vulnerability of the medical product supply chain: the wake-up call of COVID-1

The COVID-19 pandemic has brought the long-standing vulnerability of the medical product supply chain into sharp focus. Global shortages of medical products accompanied the global spread of the disease, joined by high prices, the proliferation of suspect dealers and dramatic interventions by governments, philanthropy and industry in oftentimes-unsuccessful attempts to secure solutions. Much attention has focused on personal protective equipment (PPE). But reported shortages have extended much further—to testing supplies, dialysis materials, pharmaceuticals and a wide range of commodities essential for daily care delivery—both for patients with and without COVID-19. PPE shortages have received particular attention because they endanger the healthcare workforce.3 But all product shortages endanger patients due to delays in care, rationing or denial of care, the use of substandard products, or heightened risk of error when using replacement products—risks that extend to increased mortality.4



MDSAP council updates guidance on conformity assessments and related requirements

“Participating regulatory bodies in the Medical Device Single Audit Program (MDSAP) published a new consolidated guidance document, MDSAP AU P0002.005 Audit Approach, which combines the former MDSAP Audit Model and Process Companion Document​ into a single source of information detailing the process for auditing the quality management systems of medical device manufacturers. The MDSAP Council also added annexes providing further details and guidance on assessing conformity for each audited process; giving deadlines for submitting adverse events reports and advisory notices; and outlining requirements for written agreements between manufacturers and suppliers, with references to key clauses from international medical device quality management standard ISO 13485:2016.



IMDRF Proposes Update on Post-Market Medical Device Studies

The International Medical Device Regulators Forum (IMDRF) has reportedly proposed an update to its guidance document on post-marked clinical follow-up (PMCF) studies for medical devices. According to a posting last month to the website of the Regulatory Affairs Professionals Society (RAPS), the update outlines the general principles that should inform PMCF studies for medical devices, when a PMCF study is indicated, the design and implementation of such studies, and the use of clinical information resulting from the study. The update does not apply to in vitro diagnostic devices. The IMDRF is a forum of medical device regulators from around the world focused on the harmonization of international medical device regulations. Current members of the IMDRF include the U.S., the European Union (EU), China, Japan, Australia, Brazil and Canada.



Building resilience into clinical trial design and conduct during the pandemic

“On 19 March, the MHRA first produced guidance for researchers on managing clinical trials of investigational medicinal products (IMPs) during the pandemic.  This guidance constituted details about a collection of established flexibilities and technologies that are available, but little used, despite their regulatory acceptance. The pandemic has required us all to adopt new ways of working and many trial sponsors have taken advantage of the available flexibilities to support the safe initiation and ongoing conduct of trials in both COVID-19 and non-COVID-19 indications. We have now published updated guidance and are encouraging trial sponsors to embed these flexibilities into their business-as-usual activities, where appropriate, in order to build resilience into new and ongoing trials during the continuing pandemic.”




With new guidance, FDA moves toward uniform postmarketing reporting

“A new draft guidance related to postmarketing requirements and commitments is available from the US Food and Drug Administration (FDA). The document details how drug and biologics marketers will use two forms for online submission of annual status report and other required postmarketing information. The forms, FDA 3988 and 3989, are the mechanisms by which applicants will fulfill requirements for annual reporting on the status of postmarketing requirements (PMRs) and postmarketing clinical trials (PMCs) if required to do so under section 506B of the Federal Food, Drug, and Cosmetics act (FD&C Act), or if PMCs are agreed upon by applicants and FDA.”



Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry

“This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic.”


New online platform for scientific advice

“From 19 October 2020, developers of human or veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform to request scientific advice At any stage of a medicine’s development, the developer can ask for guidance and direction from EMA, known as scientific advice, on the best methods and study designs to generate robust data on how well a medicine works and how safe it is…The IRIS platform will provide a single space for applicants and EMA to submit requests, communicate, share information and deliver documents concerning each scientific advice procedure.




USFDA inspections taking longer time than usual due to COVID-19 safety protocols

“US drug regulator, Food and Drugs Administration (USFDA), took almost a month to complete the inspection of the facility of Sun Pharma’s New Jersey subsidiary Ohm Laboratories early this year. The Ohm Laboratories plant makes prescription and OTC drugs in solid dosage forms. The USFDA also took almost a month to complete an inspection of oral solid manufacturing facility at Dayton, New Jersey of AuroLife, a wholly owned subsidiary of Aurobindo Pharma. Both inspections were conducted during January – February this year.The inspection of Lupin’s Somerset facility in New Jersey, which began on September 17, is still under way.”


A Culture of Responsibility: Laboratory Safety at the FDA

A cornerstone of the U.S. Food and Drug Administration’s scientific work is to ensure that we operate our laboratories in a safe and secure manner. October 2020 is the seventh anniversary of Biosafety & Biosecurity Month, an initiative begun at NIH to raise awareness and improve the effectiveness of biosafety programs nationwide. This year’s theme is The Role of Biosafety and Biosecurity in Mitigating Emerging Risk, and the Association for Biosafety and BiosecurityExternal Link Disclaimer is focusing activities on identifying best practices and lessons learned from the COVID-19 pandemic. As a nation, we have made significant changes to minimize the risks of the current international public health crisis, one that has profoundly upended our professional and personal lives. “