FDA accepts for review an Acorda Therapeutics NDA for Inbrija (inhaled levodopa) for treating symptoms of Off periods in people with Parkinsons diseas...
Federal Register final rule: FDA amends its regulations on data acceptance from clinical investigations for medical devices conducted outside the U.S....
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.
A plaintiffs law firm says Forest Pharmaceuticals misled the Justice Department and FDA when it negotiated 2010 settlements involving misbranding of i...
FDA releases its latest batch of Warning Letters that includes Casmara Cosmetics and Pacific Hospital Supply Co.
CDER issues a MAPP on procedures for issuing and overseeing clinical holds for INDs.