BioSpace

FDA’s CRL transparency policy is boosting biopharma accountability

Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more ...

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.

US FDA clarifies policies on compounding of GLP-1 medicines

April 1 (Reuters) - The U.S. Food and Drug Administration on Wednesday clarified its policies on compounded versions of popular GLP-1 drugs, signaling tighter limits on their production as national ...
MedPage Today

Lowering FDA's Drug-Approval Standards Is a Lose-Lose

Last week, FDA Commissioner Marty Makary, MD, MPH, announced plans to officially lower the standard for how many clinical trials are needed to approve a new drug -- from the long-standing expectation ...