This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...

The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...

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

Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from ...

New FDA guidance on the use of antibiotics in food-producing animals has prompted criticism that it fails to consider the impact on human health.

The guidance encourages the use of Bayesian statistics in drug trials. Instead of starting from scratch and only adding new ...

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

The proposed recommendations are intended to safely expedite approvals of promising therapies for multiple myeloma, but one expert is skeptical about the likelihood of industry compliance.

Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.

FDA proposes MRD-negative and complete response endpoints to fast-track multiple myeloma drug approvals, pushing deeper molecular results over ORR.

Public health advocates say the agency’s recommendations for industry are too weak, especially with antibiotic use on the rise.

Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and sweeping changes to vaccine policy.