Bayer Pharmaceuticals' chief operating officer said the head of the top U.S. drug regulator recently reassured industry ...

The head of the Food and Drug Administration said the agency will soon unveil a new framework detailing what companies must ...

This approval marks the 46th successful regulatory inspection for QPS India over the past two decades, including previous audits by the US FDA, EMA, UK MHRA, WHO, ANVISA, NPRA, NABL, GCC ...

Furness comes to CHPA from the Food and Drug Administration where he spent more than 25 years in various leadership roles.

The Food and Drug Administration should look for ways to streamline regulations on new U.S. drug manufacturing facilities to ...

This article is the latest in the Health Affairs ... of FDA’s Centers and programs. The proposal reportedly would: Consolidate all current Centers' product review, approval and regulatory ...

70. Health and Human Services Secretary Robert F. Kennedy Jr. has railed against what he sees as a “revolving door” between workers at drug companies and the Food and Drug Administration.

Medical device maker ICU Medical changed the designs of infusion pumps made in Minnesota without properly clearing important regulatory checks after a recent recall, according to a Food and Drug ...

a regulatory affairs analyst at the Defense Health Agency Research and Development-Medical Research and Development Command’s Office of Regulated Activities. “AI is transforming how drug ...