Federal Register notice: FDA seeks comments on its announced intention to exempt certain flow cytometer instruments from premarket notification requir...
Researchers say drug sponsors and FDA can do a better job of communicating non-efficacy benefits arising from non-inferiority trials.
FDA clears a CurvaFix 510(k) for the CurvaFix Intramedullary Rodscrew for use in pelvic trauma surgery.
FDA clears an Instrumentation Laboratory 510(k) for the GEM Premier ChemSTAT in vitro diagnostic analyzer with Intelligent Quality Management.
FDA approves a Janssen Pharmaceuticals NDA for Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for treating depression ...
American local governments say they plan to continue using CanaRx to import drugs for their employees despite an FDA Warning Letter issued to the onli...
Federal Register notice: FDA classifies software applications for contraception into Class 2 (special controls).
Alnylam Pharmaceuticals says it will complete its NDA rolling submission for givosiran, indicated for treating acute hepatic porphyria after reporting...