RA/QA News Roll: Late November 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 and the Administration Transition
President-elect Donald Trump has announced his intention to nominate Jim O’Neill as Deputy Secretary of HHS. In this role, O'Neill would serve as the principal deputy to the Secretary of HHS. O’Neill was previously considered as a candidate for FDA commissioner during Trump's first term. If confirmed, he would significantly influence the FDA through his position at HHS.
The Department of Government Efficiency (DOGE) commission, tasked with reducing government spending, highlighted in a recent tweet that Congress has allocated over $516 billion to programs with expired authorizations. Vivek Ramaswamy, a co-leader of DOGE, emphasized that unauthorized spending should be halted. Notably, this includes funding from the 21st Century Cures Act, which supports the FDA's ability to hire senior scientific staff at competitive salaries comparable to the private sector.
Bloomberg reports that Elon Musk and Vivek Ramaswamy are also considering a policy that would require federal workers to be in the office five days a week. One of the intended outcomes of this policy is to encourage "voluntary terminations," meaning it would incentivize staff to quit federal service. More in the Wall Street Journal here.
FDA Guidances, Regulations, and Related Documents
The FDA has finalized a crucial guidance document on the use of circulating tumor DNA (ctDNA) in solid tumor drug development. The Federal Register notice indicates that the modifications from the draft to the final version of the guidance are relatively minor in scope. 💊
The FDA has released a new draft guidance for evaluating ovarian toxicity in premenopausal adults during the development of oncology drug products. This guidance follows a recent meeting focused on fertility issues related to oncology treatments. According to the brief guidance, sponsors are advised to assess ovarian toxicity in relevant clinical trials that include premenopausal adults with ovaries. It also specifies that ovarian function should be evaluated using particular clinical measures on a pre-determined timeline. 💊
The FDA has released a new guidance document titled "Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects." The Ames test is widely used to assess whether drugs are potentially genotoxic and thus carcinogenic. 💊
The FDA's CDRH has released an overview of the regulatory science areas of interest for which it is seeking industry assistance. This request is part of its annual Broad Agency Announcement. 💉
The FDA has issued two final guidance documents concerning 510(k) submissions for orthopedic non-spinal bone plates, screws, and washers. The first guidance, titled "Orthopedic Non-Spinal Bone Plates, Screws, and Washers—Premarket Notification (510(k)) Submissions," provides recommendations for information to include in 510(k) submissions for these devices. The second guidance, "Orthopedic Non-Spinal Metallic Bone Screws and Washers—Performance Criteria for Safety and Performance Based Pathway," outlines performance criteria under the Safety and Performance Based Pathway (SPBP). 💉
The FDA has issued a final guidance document titled "510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review." This guidance outlines the agency's current thinking on the 510(k) Third Party (3P510k) Review Program and the review of EUA requests by third-party review organizations. 💉
The FDA has released a draft guidance document titled "Frequently Asked Questions—Developing Potential Cellular and Gene Therapy Products." This guidance addresses common inquiries and challenges encountered during the development of cellular and gene therapy (CGT) products, covering areas such as regulatory review, chemistry, manufacturing, and controls (CMC), pharmacology/toxicology, clinical considerations, and clinical pharmacology. The document compiles questions frequently posed to the FDA OTP and aims to facilitate the development of safe, effective, and high-quality CGT products. 💊
The FDA has released 29 new draft Product-Specific Guidances (PSGs) to assist in the development of generic drug products. Notable among these are guidances for aripiprazole (Abilify), allopurinol (Zyloprim), and clonazepam (Klonopin). Additionally, the FDA has revised 31 existing PSGs to reflect updated recommendations. 💊
Advocacy groups and pharmaceutical companies have submitted comments on the FDA's draft guidance titled "Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs." A recurring theme in these comments is a request for the FDA to provide a clearer definition of "representativeness" concerning study populations relative to the U.S. The draft guidance emphasizes that the applicability of multiregional clinical trial results to the U.S. population is a paramount consideration for the FDA. However, stakeholders seek more detailed criteria to ensure that study populations accurately reflect the demographic and clinical characteristics of U.S. patients. 💊
FDA General
The FDA and the American Association for Cancer Research (AACR) have announced a workshop titled, "To Test or Not to Test – That is the Question: DPD Deficiency and Weighing Potential Harms." The workshop will explore the considerations for testing dihydropyrimidine dehydrogenase (DPD) deficiency in patients who are prescribed fluoropyrimidine drugs as part of their cancer treatment regimen. 💊
The FDA has detailed its initiatives to enhance health care providers' comprehension and use of lactation information in drug labeling. Based on findings from 25 focus group discussions, the FDA acknowledges the necessity to refine communication methods regarding the safety of drugs for breastfeeding individuals, aiming to better serve time-constrained HCPs. 💊
The FDA has received a series of comments on its proposed rule to reclassify antigen, antibody, and nucleic acid-based Hepatitis B virus assay devices. Most of these comments strongly support the reclassification, although a few suggest further modifications to the rule. 💉
The FDA has renewed the charter for its Oncologic Drugs Advisory Committee (ODAC) for an additional two years. The charter is now set to expire on September 1, 2026, unless it is renewed again. 💊
STAT News reports that Peter Marks, the director of the FDA’s CBER, plans to emphasize the value of immunizations in the upcoming administration. Marks anticipates a robust dialogue about the benefits and risks associated with vaccines, particularly COVID-19 vaccines and potentially pediatric vaccines. He has also repeatedly affirmed his commitment to remain at the FDA as long as he is welcome. 💊
The FDA's CDRH has initiated a communications pilot program to enhance the medical device recall process. This initiative seeks to provide early alerts regarding potentially high-risk device removals or corrections, specifically targeting cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology devices. The goal is to improve the timeliness of communications about corrective actions being undertaken by companies, especially in situations where the FDA has not yet determined that the actions meet the regulatory definition of a recall. 💉