RA/QA News Roll: Mid August 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.
In headline news, CDRH has unveiled the roster of its new Digital Health Advisory Committee, including the industry representative pool, and announced the date of its first meeting. The meeting will focus on total product lifecycle considerations for Generative AI-enabled medical devices. Planned topics include the impact of gen AI on the safety and effectiveness of medical devices utilizing this technology.
Also, in some interesting reporting, The New York Times recently explored how hot summers can impact the efficacy of medications delivered by mail. While the FDA has strict guidelines for packaging, storing, and transporting drugs between manufacturers, wholesalers, and pharmacies, these rules do not extend to the transportation of medications directly to patients.
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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 released a final guidance document on dose optimization for oncology drugs. The final guidance emphasizes the FDA’s availability to provide product-specific advice, noting that there is no one-size-fits-all approach. It also clarifies the collection and analysis of key pharmacologic data. 💊
FDA General
The most recent CDRH sterilization town hall featured staff from CDRH’s Office of Product Evaluation and Quality (OPEQ) and Office of Strategic Partnerships and Technology Innovation (OST), who discussed bioburden testing, bacterial endotoxin evaluations, and packaging integrity for sterile medical devices. Tamara Rosbury from OST opened the town hall, stating that the FDA is "actively exploring where opportunities might exist" to harmonize sterilization requirements internationally while acknowledging that different jurisdictions may have varying technical standards. The town hall did not specify what global harmonization sponsors might expect. The next town hall is scheduled for September 11, 2024. 💉
CDRH has released a new discussion paper focused on Health Equity for Medical Devices. The paper addresses the FDA's efforts to enhance the study of devices to ensure they perform effectively across diverse patient populations, highlighting concerns such as those experienced with Pulse Oximeters, which showed reduced accuracy in individuals with greater skin pigmentation. The paper outlines considerations for study design and data evaluation and invites public feedback through a series of posed questions. 💉
The FDA has issued a pair of contract notices indicating its intention to screen and surveil non-sterile OTC monograph drug products for microbial contamination. The FDA noted increasing awareness of drug product recalls and adverse events due to microbial contamination. The agency is evaluating the presence of microbial contamination in certain drugs on the market and aims to alert drug manufacturers and the public to the risks associated with these products. 💊
The FDA has issued a quarterly update to its Postmarket Requirements and Commitments database. 💊
The CBER is holding a science symposium from September 16-18. The symposium will focus on six topics: (1) emerging and re-emerging diseases; (2) advanced manufacturing and analytics, including new and emerging technologies; (3) immune response to vaccination; (4) methods and biomarker discovery for product safety and quality; (5) advances in computational science supporting biologics’ evaluation; and (6) cell, tissue, and gene therapy. 💊
The FDA is now accepting a new round of applications for its Advancing Real-World Evidence program. Requests for submissions are due by September 30. 💊
The FDA has announced an invitation for pharmaceutical companies to participate in its Office of Pharmaceutical Quality’s (OPQ) Experiential Learning Site Visit Program (ELSVP). The program allows companies to host FDA staff at their facilities, providing regulators with a better understanding of product manufacturing processes. This initiative is particularly beneficial for regulators with limited experience outside of government. 💊
The FDA has announced an extension of the comment period for its amended monograph for M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use. The extension is due to technical difficulties with the OTC Monographs@FDA portal, which is preventing the posting of comments on the proposed order. Comments will instead be accepted through Regulations.gov. 💊
The FDA has announced plans to hold a meeting focused on its new Rare Disease Hub. The meeting will address key questions, including which rare disease-related scientific, regulatory, or policy issues should be prioritized by the hub and what activities and approaches it should undertake. 💊
Governing
The REMEDY Act, officially known as the Reforming Evergreening and Manipulation that Extends Drug Years Act, has been introduced by Senators Richard Durbin (D-Ill.) and Bill Cassidy (R-La.) to promote generic drug competition. The legislation seeks to change the FDA's review process for generic drug applications when existing patents are involved. Currently, the FDA enforces a 30-month automatic stay of approval if there is a challenge to a listed patent. Senators Durbin and Cassidy have noted that this 30-month stay allows brand-name manufacturers to secure numerous patents, thereby incentivizing patent accumulation. The REMEDY Act aims to limit the 30-month stays to just a single patent. 💊