RA/QA News Roll: Late 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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Here are some key items from the past couple of weeks.

FDA Guidances and Related Documents

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• An updated guidance on Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities. This guidance document, originally implemented during the Covid-19 pandemic, has now undergone long-planned revisions.

• A final guidance document outlines a policy for the testing of alcohol, specifically ethanol and isopropyl alcohol, to detect the presence of methanol.

• A final guidance document provides details on evaluating the benefits and risks associated with new drug and biological products.

• A guidance document details FDA’s approach to regulating Non-Invasive Remote Monitoring Devices for Patient Monitoring. This policy was initially issued in draft form during the pandemic.

• An updated guidance document explains how life sciences companies can provide requested off-label use information to healthcare providers.

• A final guidance document explains the Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.

• The FDA has submitted two pharmaceutical compounding guidance documents to the White House's Office of Information and Regulatory Affairs for review. These documents pertain to compounding practices involving bulk drug substances.

• The FDA, along with Canadian and U.K. regulators, has released a new document outlining "guiding principles" for predetermined change control plans (PCCPs) concerning Machine Learning-Enabled Medical Devices.

FDA General

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• FDA host a webinar on its proposed Laboratory Developed Test (LDT) rule today, Oct. 31. The hour-long webinar will feature a Q&A session “based on questions submitted prior to the webinar.” Questions will not be taken live.

• Earlier this month, FDA Commissioner Robert Califf delivered remarks at the ISPE expo in Las Vegas, with a primary focus on the issue of drug shortages.