FDA approves an Amgen supplemental NDA to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the prescribing information f...
FDA commissioner Scott Gottlieb says he agrees with the Government Accountability Office that the agency needs to develop and use performance metrics ...
FDA issues a draft guidance responding to questions raised about the legal requirement to offer a priority review voucher to sponsors of certain medic...
Federal Register notice: FDA withdraws approval of 22 ANDAs from multiple applicants.
Federal Register proposed rule: FDA proposes to implement regulations regarding internal agency supervisory review of certain decisions related to dev...
Federal Register notice: FDA submits for OMB clearance a new information collection entitled Use of Public Human Genetic Variant Databases To Support ...
Baxter International expands its recall of one lot of Nexterone (amiodarone HCl) 150 mg/100 mL premixed injection to include a second lot due to the p...
FDA warns Imprimis Pharmaceuticals about many false or misleading claims in promotional materials for its compounded drugs.