FDA Review posts the Federal Register notices for the week ending 9/6/2019.
FDA Review posts product approval summaries for the week ending 9/6/2019.
FDA issues a final guidance entitled Acceptance Review for De Novo Classification Requests.
Federal Register notice: FDA determines the regulatory review period for La Jolla Pharmaceuticals Giapreza (angiotensin II).
Federal Register notice: FDA makes available a final guidance entitled Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy f...
Federal Register notice: FDA seeks comments on an information collection extension for Guidance for Industry on E6 (R2) Good Clinical Practice; Intern...
FDA clears a Bardy Diagnostics 510(k) for its 14-Day version of the Carnation Ambulatory Monitor, a P-wave heart monitor.
Endo International files a BLA for collagenase clostridium histolyticum for treating cellulite in the buttocks.