RA/QA News Roll: Late June 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 recently published a new final guidance that addresses the presentation of quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements. This guidance provides comprehensive instructions and recommendations on how such information should be effectively conveyed to consumers in DTC promotional materials.

• FDA released a new draft guidance document addressing the prohibition on wholesaling for outsourcing pharmacies engaged in the compounding of drugs.

• FDA released a much-awaited draft guidance addressing the considerations for clinical investigations of psychedelic drugs. This guidance offers primarily high-level recommendations with a focus on academic medical centers. It sheds light on the numerous practical challenges associated with conducting research in the evolving field of psychedelic drugs and underscores the complex regulatory landscape surrounding these substances.