Federal Register notice: FDA sends to OMB a proposed information collection entitled Assessment of Terms and Phrases Commonly Used in Prescription Dru...
Federal Register notice: FDA seeks comments on a proposed study entitled Medical Conference Attendees Observations About Prescription Drug Promotion....
Federal Register notice: FDA seeks comments on a proposed Survey of Drug Product Manufacturing, Processing and Packing Facilities 21 CFR parts 210 an...
FDA clears a 410 Medical 510(k) for its LifeFlow device for rapid delivery of blood and blood components, in addition to its previous clearances for c...
FDA makes modernized changes to its Phonetic and Orthographic Computer Analysis (POCA) program, the agencys software tool for determining orthographic...
House Energy and Commerce Committee leadership denounces the White House after it blocked FDA commissioner Stephen Hahn from testifying before the Com...
Medimetriks Pharmaceuticals says it received a Type C Meeting written response from FDA on MM36 (difamilast) for the topical treatment of mild to mode...
FDA grants Junshi Biosciences an orphan drug designation for toripalimab and its use in treating soft tissue sarcoma.