FDA Matters founder Steven Grossman says FDA commissioner Martin Makary and the Trump administration are at a crossroads and need to decide whether th...
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...
Three FDA staffers discuss the agencys efforts to advance the use of digital health technologies in clinical trials.
FDA commissioner Marty Makary says the agency is exploring the use of a new drug approval pathway for rare diseases and incurable conditions.
An FDA Matters blog post analyzes a leaked document purporting to show a 17% decrease in FDA budget authority spending for FY 2026 from the FY 2023 ap...
Two reports highlight U.S. dependence on foreign sources for APIs and finished drugs and call for urgent steps to reduce that dependence.
