RA/QA News Roll: March 2023

Here's what's happening at FDA and across the broader life science RA/QA space.

Each month, we’ll be posting a roll-up of news and industry happenings curated for RA/QA professionals 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’s our first list highlighting industry happenings from the past few weeks.

From the FDA

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• The FDA has issued a report on the use of artificial intelligence in advanced drug manufacturing. The document highlights various possible applications of AI, such as process monitoring and fault detection, trend monitoring, and advanced process controls, as well as process design and scale-up. However, the report acknowledges that these applications pose unique challenges and issues, such as data integrity concerns, ownership of records, and determining the level of FDA oversight required for AI. (FDA / fda.gov)

• The FDA has announced the creation of a Digital Health Technology Steering Committee composed of high-level personnel from CDER, CBER, and CDRH, including the Digital Health Center of Excellence, as well as the Oncology Center of Excellence and the Office of Clinical Policy and Programs. (FDA / fda.gov)