Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been ...

The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay ...

The Food Traceability Rule establishes additional recordkeeping obligations for entities that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List (FTL). These requirements ...

Today, the FDA issued draft guidance outlining a new regulatory pathway intended to help sponsors gain approval for highly ...

FDA allergen thresholds offer food brands science-based guidance on managing cross-contact risks and using advisory ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Mario Aguilar covers technology ...

Just before the change in administration, the Food and Drug Administration (FDA) made headlines by revoking approvals to use the color additive FD&C Red Dye No. 3 in food after January 15, 2027. This ...

The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments ...

Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile ...

(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...

Rick Abramson, formerly a chief medical officer at a subsidiary of Harrison.ai, which develops AI products to interpret ...