The International Council for Harmonization endorses and releases for comment its Q1 guidance on drug product stability testing.
FDA says it has received reports of adverse effects associated with using unapproved compounded topical finasteride products.
FDA Office of Prescription Drug Promotion director Catherine Gray and deputy director Mark Askine resign their posts in the wake of their Office havi...
FDA warns San Jose, CA-based Noah Medical about Quality System violations in its manufacturing of the Galaxy System bronchoscopes and accessories.
AstraZeneca and Daiichi Sankyo report interim data from a Phase 3 trial that showed Enhertu (trastuzumab deruxtecan), in combination with Perjeta pert...
The Democratic Lieutenant Governors Association writes president Donald Trump urging him to support and safeguard the integrity of key federal science...
Federal Register notice: FDA reschedules a previously planned drug safety advisory committee involving opioid overdose risk studies.
A report on the 2024 Global Summit on Regulatory Science calls for a collaborative global effort to harness artificial intelligence to meet new demand...
