FDA clears a Phonak 510(k) for its Phonak Lyric hearing aid and a self-replacement option to reduce office visits.
Federal Register notice: FDA makes available a veterinary-use draft guidance entitled #290 (VICH GL61) Pharmaceutical Development.
An unusually strident Wall Street Journal editorial apologizes to its readers for supporting FDA commissioner Robert Califfs appointment now that hes ...
Regeneron faces a potential approval delay on its supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patien...
A just-introduced bill, Fixing Administrations Unethical Corrupt Influence Act, restricts top federal health officials at FDA, CDC and NIH from cashin...
FDA increases its surveillance of promotional materials during inspections, according to a client bulletin by Arnall Golden Gregory.
FDA announces an 8/16 public meeting on Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials to discuss approaches to developing drugs...
FDA issues Eugia Pharma Specialities its fourth Form FDA-483 of the year after concluding an inspection of the firms formulation manufacturing facilit...
