RA/QA News Roll: Late April 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.
FDA Guidances, Regulations, and Related Documents
The FDA has issued its new final rule on Laboratory-Developed Tests (LDTs). The rule outlines a phased-in approach to regulatory enforcement over four years, spanning five stages. While the final version provides added flexibility for certain products through new enforcement discretion, several unanswered questions remain regarding implementation and expectations. 💉 Read our full analysis:
CBER has issued an updated Standard Operating Policies and Procedures (SOPP) document regarding the scheduling and documentation of liaison meetings with industry trade organizations. The document now includes a new policy stating that CBER will not review or approve meeting summaries submitted by industry. While industry trade organizations may submit a meeting summary, CBER explicitly states that it will not review or endorse these summaries. 💊
The FDA has released an updated Data Standards Catalog, now labeled version 10.3. 💊
The FDA has issued a new final guidance document regarding the agency's recognition of the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128, Version 4. As the FDA explains, this standard outlines a system for uniform container labels for blood and blood components intended for transfusion or further manufacturing use. 💊
The FDA has released a pair of new cell therapy guidance documents. The first document is titled "Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products." The second document is "Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products." 💊
The FDA issued three new guidance documents regarding eligibility for oncology clinical trials. These documents cover laboratory values, performance status, and washout periods and concomitant medications. Over the years, the FDA's Oncology Center of Excellence has released several related guidance documents to encourage the enrollment of representative patients in clinical trials and minimize unnecessary enrollment criteria that can restrict participation. 💊
FDA General
In the latest negotiating meeting minutes for the reauthorization of the OTC Monograph User Fee program (OMUFA), several new details emerged:
The industry has requested that the FDA create five new Manuals of Policies and Procedures concentrating on the approval process for OTC products.
The industry is seeking new guidance on filing eligibility determinations.
The FDA and industry are discussing improvements to an existing goal of digitizing all existing paper documents.
The FDA has put forward several proposals related to product quality enhancement.
CDRH has introduced a new public dataset aimed at aiding chemistry labs in verifying the reliability of chemical characterization methods used to evaluate the biocompatibility of medical devices. The dataset's purpose is to enable labs to ensure the effectiveness and reliability of their chemical characterization methods. Biocompatibility assesses the safety of a device when it interacts with a person, whether temporarily or over prolonged periods, such as with an implanted device.
A new FDA webpage highlights Project Asha, a focus of the FDA Oncology Center of Excellence (OCE). This project aims to improve access to oncology clinical trials in India as part of the White House Cancer Moonshot Program. The page points out that despite India's nearly 20% share of the global population, only 1.5% of global trials are conducted there. 💊
A new report from the FDA examines the performance of drug companies in fulfilling postmarketing requirements and commitments for Fiscal Year 2022. Although this assessment predates the Food and Drug Omnibus Reform Act, which grants the FDA increased authority to enforce these studies, it highlights significant gaps requiring FDA attention. The report indicates that only 82% of annual status reports on confirmatory study requirements were received on time, with 7% not received at all. Additionally, 30% of all postmarketing requirements were "off-schedule," meaning they did not adhere to their original timelines. 💊
CDRH has released a pair of reports outlining its objectives in two critical areas: medical device safety and innovation. Each report lists three ambitious action items. According to CDRH Director Jeff Shuren, these are focal points for "this year," although the specifics of implementation remain unclear. The goals range from high-concept initiatives like "reimagining our premarket review program" to more specific objectives such as "launching a new home as health care hub" and enhancing device recall policies. 💉
The FDA has announced its next town hall meeting for the OTP, scheduled for June 4. This meeting will concentrate on "CMC readiness for gene therapy" applications for approval. 💊