RA/QA News Roll: Late July 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 as well as 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

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• FDA released an updated version of its guidance on the Qualification of Medical Device Development Tools. The original guidance was published in its final form in August 2017. The recent final version is a few pages shorter, and the changes are mostly minor procedural updates and clarifications.

• FDA has issued final guidance on CDER's Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality. It outlines the agency's approach to recognizing voluntary consensus standards relevant to pharmaceutical quality.