FDA approves a Glenmark Specialty NDA for Ryaltris (olopatadine HCl and mometasone furoate) a fixed-dose (metered) nasal spray for treating seasonal a...
Federal Register notice: FDA determines that Valeant Pharmaceuticals Pepcid (famotidine) tablets, 20 mg and 40 mg, were not withdrawn from sale for re...
Federal Register notice: FDA classifies electrocardiograph software for over-the-counter use into medical device Class 2 (special controls).
An 8/2021 FDA outsourcing facility inspection of Eagle Pharmacy (Hoover, AL) results in a five-page Form FDA 483 that cited several GMP deficiencies.
FDA approves a Pfizer NDA for Cibinqo (abrocitinib), an oral Janus kinase 1 inhibitor for treating certain adults living with refractory, moderate-to-...
FDA clears a Nextremity Solutions 510(k) for its InCore Subtalar System, indicated for reduction and internal fixation of arthrodeses, osteotomies, an...
A new Government Accountability Office report says FDA needs better planning for its recruitment and retention of medical product staff.