FDA warns Timurs (East Java, Indonesias) PT MegaSurya Mas drug manufacturing facility about CGMP violations in its production of finished pharmaceutic...
FDA warns Calvin Scott & Company about CGMP violations in its production of finished drugs.
Federal Register notice: FDA announces a 10/27 virtual public meeting to discuss proposed recommendations for reauthorizing the medical device user fe...
FDA makes availabile a revised draft guidance on Pharmacokinetics in Patients with Impaired Renal Function Study Design, Data Analysis, and Impact on...
In a move to shore-up public confidence, nine companies developing Covid-19 vaccines have pledged to uphold scientific, regulatory and ethical rigor a...
A Duke Medical School dermatology professor calls on FDA to require consistent safety labeling for all approved hedgehog inhibitors.
Four drug companies suggest changes to a proposed FDA study of multiple indications in DTC television ads.
FDA approves an Athena Bioscience NDA for Qdolo (tramadol hydrochloride) oral solution 5mg/1ml, an opioid agonist indicated in adults for managing pai...