FDA cracks down on sponsor and researchers’ failure to publish trial data

The European Medicines Agency (EMA) has taken a similar transparency stance with clinical trials. In October 2023, the EMA ...
Regulatory Affairs Professionals Society

FDA nudges sponsors, researchers to publish trial results

The US Food and Drug Administration (FDA) has notified more than 2,200 medical product manufacturers and researchers to ...
Becker's Hospital Review

5 FDA moves shaping drug development, oversight

FDA moves shaping drug development and oversight include new gene therapy guidance, clinical trial transparency efforts, and recent drug approvals.
Regulatory Affairs Professionals Society

FDA drafts guidance on using next-generation sequencing to assess gene therapy safety

The US Food and Drug Administration (FDA) has released draft guidance on how sponsors can utilize next-generation sequencing ...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

FDA renews criticism of trial sponsors over transparency

For now, the FDA is simply asking trial sponsors to make sure they meet the required reporting standards, but it has also ...
Applied Clinical Trials Online

FDA Reminds More Than 2,200 Sponsors and Researchers to Report Clinical Trial Results

1. FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results. News release. FDA. April 13, 2026.

F.D.A. Calls on Drug Developers to Publish Missing Data from Thousands of Trials

The Food and Drug Administration will announce on Monday that it has sent over 2,200 letters pressing drug manufacturers, ...

FDA asks drug manufacturer for more safety data on Foundayo GLP-1

The FDA has asked Eli Lilly for safety data on its weight loss pill Foundayo.
The American Journal of Managed Care

FDA Guidance to Remove One of the Largest Barriers to Biosimilar Development

The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...
The American Journal of Managed Care

FDA Signals Potential Expansion of Testosterone Therapy to Treat Low Libido in Idiopathic Hypogonadism

FDA is encouraging supplemental NDAs for TRT to treat low libido in idiopathic hypogonadism, reflecting preliminary ...