RA/QA News Roll: Mid October 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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Before getting into our latest new roll, we wanted to highlight a recent article by Biocentury's Steve Usdin on how the Israeli biotech sector is managing the ongoing events unfolding there, including preparations for armed conflict in the region. The article also highlights that some manufacturing facilities are situated relatively close to Gaza, although most are not.

Here are some key items from the past couple of weeks.

FDA Guidances and Related Documents

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• The FDA has released updated guidance regarding the use of Electronic Submission Template and Resources (eSTAR) through the CDRH Portal. Starting from October 1, 2023, all 510(k) submissions are mandated to utilize the eSTAR template. This final guidance provides the following minor updates:

  • Withdrawal requests, which have previously been submitted via email continue to be exempt from electronic submission requirements.

  • While use of eSTAR will be required starting on October 1, 2023, there are currently known technical reasons that preclude electronic submission via the CDRH Portal and impacted submissions will need to be mailed to the CDRH Document Control Center.

• The recently updated CDER Manual of Policies and Procedures is centered on generic drug Suitability Petitions. These revisions, the first since 2018, align with the latest changes introduced under the GDUFA III user fee program.

• The FDA has released a new guidance document focused on stimulant use disorders and the development of drugs for their treatment.

• A new Electronic Submission Template for Medical Device 510(k) Submissions has been introduced. As of October 1, 2023, all 510(k) submissions are mandated to be submitted electronically in accordance with the guidelines provided in this document.

• The FDA has issued a new document addressing quality considerations for topical ophthalmic drug products.

• The FDA has issued updates to its guidance documents concerning the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices and Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. These updates aim to align the guidance with the most recent edition of relevant FDA-recognized consensus standards.

• The FDA has released an updated Compliance Program Manual for the Inspection of Medical Device Manufacturers. This updated guide is intended to provide clarity on existing processes, integrate new authorities, and update references and program contacts.

FDA General

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• The FDA released its newly proposed Laboratory Developed Tests (LDTs) rule. In short, it seeks to officially classify LDTs as medical devices according to the FDA's perspective. Additionally, it outlines a five-stage process to gradually phase out historical enforcement discretion over these products, spanning a minimum of five years. The rule is open for public comments until December 6, 2023.