RA/QA News Roll: Mid December 2023
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 also 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 and Related Documents
The FDA has released a highly anticipated guidance document concerning verification systems under the Drug Supply Chain Security Act (DSCSA). These systems are designed to confirm the authenticity of pharmaceutical products and prevent counterfeiting. 💊 Read our analysis:
The FDA has issued two guidance documents outlining its interim policies for pharmaceutical compounding. One document pertains to outsourcing pharmacies (503B facilities), and the other to compounding pharmacies (503A facilities). 💊
The FDA has submitted a Q&A guidance document on "conducting remote regulatory assessments" to the White House for review and clearance. This document represents a revised draft version of the guidance initially released in July 2022. The original guidance received mostly positive feedback from the industry, although many comments requested further clarification on numerous aspects.
The FDA has forwarded its Quality Management System Regulation (QMSR) final rule to the White House for the final review and clearance process. Despite the FDA's self-imposed deadline of publishing the rule by the end of December 2023, it may still take some time to complete the Office of Information and Regulatory Affairs (OIRA) reviews, which typically vary in duration depending on the rule's complexity and industry feedback. As a result, it is anticipated that the rule will be released either in late December or early in the first quarter of 2024. We wrote extensively on the proposed regulation when it was first released in 2022. 💉
The FDA has introduced proposed changes to reform both its human foods program and its Office of Regulatory Affairs. These changes are currently undergoing review by the Department of Health and Human Services (HHS), marking the initial step in a multi-phase external review process.
The FDA has introduced its Advanced Manufacturing Technologies Designation Program, which was mandated under the Food and Drug Omnibus Reform Act (FDORA). The program's aim is to encourage the adoption of Advanced Manufacturing Technologies (AMTs) capable of either reducing drug development timelines or improving and ensuring the supply of essential medications. 💊
The FDA has announced that it is currently accepting eSTAR applications for Premarket Approval Applications (PMAs), which include various types such as original applications, panel track supplements, real-time supplements, and 180-day supplements. 💉