RA/QA News Roll: Late October 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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Here are some key items from the past couple of weeks.
💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.
FDA Guidances, Regulations, and Related Documents
The FDA has published its proposed Commitment Letter to reauthorize the Over-the-Counter Monograph Drug User Fee Program (OMUFA). Established in 2020 under the CARES Act, OMUFA is the user fee program for nonprescription drugs. The Commitment Letter outlines the fees to be paid by industry in exchange for the FDA's commitments to meet specific performance targets. It also details improvements and programs of mutual interest to both the FDA and industry. 💊
The FDA has published a Federal Register notice extending the comment period for its recent guidance on Chemical Analysis for Biocompatibility Assessments. This draft guidance, released in late September, aims to standardize approaches for chemical characterization and analysis, addressing issues such as variability in testing methods, inconsistent analytical chemistry reports among laboratories, and deficiencies commonly identified in premarket submissions. The draft guidance spans 45 pages, with approximately two-thirds consisting of appendices that provide further considerations for testing methods. The original comment deadline of November 18 has been extended to December 19. 💊
The FDA has released a collection of scientific posters ahead of its upcoming Scientific Computing and Digital Transformation Symposium. These materials offer valuable insights into the agency's internal use of generative AI, providing a comprehensive overview of its applications. The poster gallery is an excellent resource for those interested in exploring this topic further. 💊 💉
Slides are now available from the FDA’s recent IVD town hall. Brittany Schuck, Deputy Office Director of the FDA's IVD division (OHT7), provided an overview of the Total Product Life Cycle approach for IVDs. This approach encompasses pre- and post-market activities and requirements, aligning with the CDRH standard practice for device regulations. The session also introduced OHT7's leadership and its various divisions, each responsible for various IVDs and technologies. The next webinar is scheduled for December 3 and will focus on registration and listing for both IVDs and Laboratory Developed Tests (LDTs). 💉
The FDA is revising hundreds of Product-Specific Guidances (PSGs) to align with the ICH’s M13A guideline on bioequivalence for immediate-release solid oral dosage forms. This update focuses on recommendations regarding fed and fasting studies, ensuring consistency with the new M13A standards. The FDA has announced plans to issue new and revised PSGs for both complex and non-complex generic drug products, including those related to the M13A guideline. 💊
The FDA's CDRH recently held a Medical Device Sterilization Town Hall featuring a comprehensive Q&A session; the slides are now available. The discussion focused on CDRH's sterilization policies, including support opportunities for the industry, and the use of bundling for sterility-related submissions. This session is part of a series aimed at facilitating manufacturers' transition from ethylene oxide (EtO) sterilization methods. The next town hall is scheduled for November 20, with potential topics covering recent standards changes and biocompatibility assessment considerations related to sterilization changes. 💉
FDA General
Michelle Tarver is officially taking over as the Center Director of the CDRH. With over 15 years at CDRH, Tarver previously served as Deputy Center Director and Chief Transformation Officer. She was named Acting Center Director following the retirement of longtime Office Director Jeff Shuren earlier this year. FDA leadership, including Shuren and Commissioner Robert Califf, had indicated that Tarver would likely be appointed permanently. At the Medical Device Innovation Consortium’s Annual Public Forum in September, Califf noted that while the search for a permanent director was ongoing, "Michelle is certainly a great person who could very well be the permanent [director]." In her statement, Tarver expressed her honor in leading CDRH and praised the staff's commitment to public health. She stated, "As someone who has served the FDA for more than 15 years, I am immensely proud of the work we have accomplished together, always keeping the people we serve at the core of our mission. As we embark on CDRH’s next chapter, we remain committed in our service to public health and ensuring all patients in the U.S. have access to high-quality, safe, and effective medical devices." 💉
The FDA has appointed Steven Kozlowski as the new Acting Chief Scientist, succeeding David Strauss, who held the position since April following Namandjé Bumpus's promotion to Principal Deputy Commissioner of the FDA. Before this appointment, Kozlowski served as the Director of the Office of Product Quality Assessment III (OPQA III) in the Office of Pharmaceutical Quality (OPQ) within the CDER. 💊 💉
Recent research from the FDA focused on nitrosamine drug substance-related impurities (NDSRIs), a class of nitrosamines that are structurally similar to the API in a drug. The study aimed to explore methods for controlling the formation of certain NDSRIs linked to bumetanide, a medication used for treating fluid retention. The researchers discovered that adding antioxidants effectively mitigated NDSRI formation in the short term; however, some impurities still developed under long-term storage conditions. Notably, increasing the drug's pH through the addition of sodium bicarbonate demonstrated the highest overall inhibition of nitrosamine formation, surpassing the performance of the best antioxidant, ascorbic acid. The same research group conducted similar studies on metformin, yielding comparable results. 💊