RA/QA News Roll: Late 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.
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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’s CDER has published new guidance focused on product-specific guidance (PSG) meetings between the FDA and generic drug sponsors. PSGs are created by the FDA to help sponsors efficiently develop generic drugs. These PSG meetings are designed to allow sponsors of generic drugs already in development to understand how a new or pending PSG might impact their drug development program. Despite concerns raised by AAM and Teva, the FDA made only modest adjustments to an earlier draft guidance. However, one of the significant changes to the final guidance was to remove a requirement related to the timing of requests for PSG meetings, which the industry said the FDA wasn’t authorized to include. 💊
The FDA’s CDRH has released significant new guidance on Predetermined Change Control Plans (PCCPs) for medical devices. PCCPs allow sponsors to inform the FDA about all potential changes they might make to a device after approval. If the FDA approves the plan, the sponsor can implement these changes without needing to seek additional FDA approval each time. Although PCCPs have primarily been used for artificial intelligence and machine learning devices, this new guidance also extends the concept to traditional medical devices. (Brendan O’Leary, former acting director of FDA’s Digital Health Center of Excellence, has analyzed PCCPs and identified 35 examples of cleared or approved devices with a PCCP. This analysis provides valuable insights for companies looking to implement a PCCP for their own products.) 💉
The FDA has updated MedWatch Form 3500A, with older versions of the form now considered obsolete. 💊
The FDA has announced that it will host a virtual meeting on October 9 focused on the International Council for Harmonization’s M12 guideline, Drug-Drug Interaction Studies. This guideline is the first globally harmonized regulatory guidance on assessing pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters. 💊
The CDRH’s Office of Radiological Health (OHT8) has issued a Level 2 guidance update on the media types for providing electronic product user manuals. This Level 2 update allows the FDA to make minor adjustments to existing final guidance documents to address current practices without changing policies. The updated guidance specifies that Radiation Safety Reports can now be submitted directly by email to OHT8. Additionally, it includes updated contact information and directs manufacturers to OHT8, the newest Office of Health Technology within CDRH. 💉
The FDA has released final guidance on "FDA and Industry Procedures for Section 513(g) Requests for Information," which pertains to device classification. This guidance outlines the process for companies to request information about a device's classification under Section 513(g). Such requests assist companies in determining the most suitable regulatory pathway for their devices. 💉
The latest batch of industry comments on FDA's updated guidance document on demonstrating interchangeability with a reference biologic has been posted to the docket. The guidance suggests removing the requirement for "switching studies," which would simplify the process for demonstrating interchangeability. As expected, insurance and biosimilar stakeholders generally support this change. However, some other stakeholders have requested further clarification on specific points or have expressed opposition to the proposed modifications. 💊
The FDA released a final guidance document regarding its Voluntary Malfunction Summary Reporting Program (VMSR) for medical device manufacturers. The VMSR program permits certain manufacturers to submit Medical Device Reports (MDRs) on a quarterly basis. This final guidance aims to clarify the program's details but does not introduce any changes. A draft version of this guidance was previously published in late 2022. 💉
FDA General
The Government Accountability Office (GAO) has released a new report outlining how the FDA is developing an active postmarket surveillance system for medical devices. The agency plans to start active surveillance of two medical devices by December 2024 and aims to expand this system to cover additional devices over the next four years.
The FDA has announced a new grant to fund clinical trials to advance drug development for rare neurodegenerative diseases in adults and children. This grant is being offered under the Accelerated Access to Critical Therapies for ALS Act (ACT for ALS Act). 💊
The New York Times has published a report examining potential conflict of interest issues involving former CDRH Director Jeff Shuren and his wife, Allison Shuren, a partner at the law firm Arnold & Porter, who specializes in medical device regulatory issues. The FDA has acknowledged in a statement that there were certain instances from about ten years ago where Dr. Shuren should have either recused himself or sought ethics authorization to avoid any potential appearance of bias. The FDA defended Shuren in an email to MedTech Dive amid the ethics controversy raised by the Times and a patient safety advocate. 💉
