The FDA has quietly proposed legislation that would give it more authority to deem drugs misbranded in pharma DTC ads. But ...

As discussed previously (“New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the ...

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing ...

Twelve months after releasing a roadmap to shift away from animal testing requirements, the FDA has declared mission ...

The U.S. Food and Drug Administration has issued draft guidance developed through the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal ...

WASHINGTON -- The US Food and Drug Administration said Wednesday it will be lowering its targets for sodium content in processed, packaged, and prepared foods, but not to levels recommended for ...

WASHINGTON, D.C., USA — The U.S. Food and Drug Administration on Wednesday released 10 new guidelines for drug manufacturers to follow when using artificial intelligence to develop new treatments. The ...

The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...

The FDA released draft guidance indicating it may approve certain biosimilars without requiring a comparative efficacy study (CES), traditionally a costly and time-intensive step. Instead, advances in ...

The FDA is considering easing restrictions on injectable peptides, which have become more widely known due to the approval of ...