Stakeholders comment on and make suggestions to improve an FDA discussion document on patient-focused drug development.
FDA issues a guidance and technical conformance guide on bioresearch monitoring electronic submissions.
The DC federal court grants FDA summary judgment supporting its decision not to grant pediatric exclusivity to Amgens Sensipar.
The CDER Office of Prescription Drug Promotion cautions Collegium Pharmaceuticals about a misleading exhibit booth for Xtampza ER.
A plaintiffs law firm says Forest Pharmaceuticals misled the Justice Department and FDA when it negotiated 2010 settlements involving misbranding of i...
FDA warns Taiwans Pacific Hospital Supply about Quality System violations in its manufacturing of disposable medical supplies.
FDA warns Spains Casmara Cosmetics about CGMP and other violations in its production of finished pharmaceuticals.
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Genmabs Darzalex (daratumumab) is 1,939 da...