[ Price : $8.95]
FDA extends by three months the user fee review action dates on two bluebird bio BLAs for its lentiviral vector gene therapies be...[ Price : $8.95]
FDA and the medical device industry are at a standstill in their negotiations on the next five-year iteration of the medical devic...[ Price : $8.95]
A new Government Accountability Office report says FDA needs better planning for its recruitment and retention of medical product...[ Price : $8.95]
FDA approves a Glenmark Specialty NDA for Ryaltris (olopatadine HCl and mometasone furoate) a fixed-dose (metered) nasal spray for...[ Price : $8.95]
Federal Register notice: FDA determines that Valeant Pharmaceuticals Pepcid (famotidine) tablets, 20 mg and 40 mg, were not withdr...[ Price : $8.95]
Federal Register notice: FDA classifies electrocardiograph software for over-the-counter use into medical device Class 2 (special ...[ Price : $8.95]
An 8/2021 FDA outsourcing facility inspection of Eagle Pharmacy (Hoover, AL) results in a five-page Form FDA 483 that cited severa...[ Price : $8.95]
FDA approves a Pfizer NDA for Cibinqo (abrocitinib), an oral Janus kinase 1 inhibitor for treating certain adults living with refr...