Federal Register notice: FDA corrects an 11/3 Federal Register notice entitled Controlled Correspondence Related to Generic Drug Development.
Federal Register notice: FDA makes available a draft guidance on Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.
FDAs Antimicrobial Drugs Advisory Committee votes 9 to 6 against recommending approval for Bayer HealthCare Pharmaceuticals ciprofloxacin dry powder f...
Pfizer subsidiary Greenstone recalls multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets because the products have the potential...
FDA commissioner Scott Gottlieb says the agency is taking steps to improve certain drug shortages at hospitals caused by hurricanes that devastated Pu...
FDA issues a guidance answering questions about the direct marking of medical devices under the unique device identification regulation.
The Senate approves a House bill retaining FDA authority over battlefield drug and medical device decisions.
FDA approves Genentechs Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previ...