RA/QA News Roll: Late February 2024

Here's what's happening at FDA and across the broader life science RA/QA space.

This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.

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We’ve added emojis to our links to denote pharma/biologic items (💊) from device/diagnostic/digital health items (💉) when there’s a clear relevance to only one sector.

Here are some key items from the past couple of weeks.

Just a reminder that CDRH is hosting its next medical device sterilization town hall meeting today (February 29). The focus will be on the use of Device Master Files to expedite the transition from ethylene oxide-based sterilization methods to other acceptable methods. 💉

FDA Guidances and Related Documents

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• The FDA has released a new guidance document titled "Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment." This final guidance updates the FDA's September 2020 document with the same title. 💊

• The FDA has published an updated guidance on medical device user fees applicable to small businesses, outlining circumstances under which they may be exempt from these fees. 💉

• CDER has updated its Manual of Policies and Procedures (MAPP) detailing its "Network of Experts," which FDA staff utilize to acquire external expertise across scientific, clinical, medical, and other viewpoints. 💊

• CDER and CBER have issued new technical guidance concerning the reporting of listed drugs and biological products' amounts. Mandated by the CARES Act, pharmaceutical companies must furnish the FDA with annual data regarding the quantity of a drug manufactured, prepared, propagated, compounded, or processed for commercial distribution. This new guidance serves as a technical conformance guide, outlining how users can report this data utilizing CDER’s NextGen Portal. 💊

• The FDA has published a blog post spotlighting its review process for Narrow Therapeutic Index (NTI) drugs—products where slight dose variations could lead to inefficacy or danger. 💊

FDA General

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• According to a report by MedTech Dive, William Maisel, who has served as the longtime deputy of CDRH Director Jeff Shuren and as the Director of CDRH's Office of Product Evaluation and Quality, will be retiring this spring. 💉

• The CDER's Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) program has released a new report aimed at identifying educational opportunities across various topics in rare disease drug development. The report covers six topic areas and offers extensive recommendations for CDER to enhance the drug development process. (It wouldn't be surprising if lobbyists leverage this report to urge Congress to mandate some of the proposed changes at the agency.) 💊

• The FDA has issued a statement expressing concern over a troubling trend it has observed: fabricated and unreliable laboratory data being used to validate medical device applications for clearance. According to the FDA, this falsified data has been particularly prevalent in laboratories based in China and India. 💉

• "I wish Congress had – I don’t know how to say this – done its job, that would be the best because we would do better with a pathway that had the things in it," said FDA Commissioner Robert Califf at this week’s National Press Club headliners event focused on the agency’s Laboratory Developed Test proposed rule. Califf referred to legislative efforts to pass the VALID Act in prior sessions of Congress. "Rulemaking, as you know, is limited in what we can do, but it’s a start and I think it’s a very important start. I’ve recently had family members with serious cancer and it just really disturbs me that you could go to different cancer centers and get entirely different answers based on which version of the test they happen to use." 💉

• The CBER revised its operating policy document (SOPP) focused on postmarketing requirements (PMRs) and commitments (PMCs) and their internal handling processes. 💊

• The FDA recently released a new report focusing on its Drug Safety Priorities for the year 2023, highlighting its proactive steps in addressing drug impurities, enhancing overdose prevention efforts, and expanding access to opioid overdose reversal products. Notably, the report covers the establishment of the Emerging Impurities and Contaminants Committee (EICC) to manage drug impurities like nitrosamines and benzene, approval of the first nonprescription naloxone nasal spray, and the promotion of safer opioid disposal options. It also outlines efforts in risk management, including the publication of drug safety-related labeling changes and the continuation of the Prevention of Overdoses and Treatment Errors in Children Taskforce (PROTECT) initiative. Additionally, the report emphasizes the importance of stakeholder engagement and the use of social media and Drug Safety Communications to disseminate important safety information to the public. 💊

• The FDA is organizing an upcoming workshop dedicated to its Accreditation Scheme for Conformity Assessment (ASCA) and its initiatives to broaden the program's scope. 💊

• CDRH has recently updated its Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) program webpage. This program encompasses a collaborative community aimed at enhancing the interoperability of diagnostics data, addressing a significant challenge during the COVID-19 pandemic. 💉

Governing

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• Senators Richard Durbin (D-Ill.) and Mike Braun (R-Ind.) penned a letter to FDA Commissioner Robert Califf urging prompt action to modernize enforcement tools to align with current platforms and methods for promoting prescription drugs and biologics. They emphasized prioritizing shielding children from harmful and inaccurate medical advice. Notably, the senators pointed out that the FDA's social media guidance document, last updated in 2014, fails to address the emergence of platforms such as TikTok. They highlighted concerns about gaps in the FDA's oversight of direct-to-consumer promotions on social media, which are being exploited to the detriment of children and patients. The FDA was urged to assess whether it requires additional statutory authority to take decisive action. 💊