Four stakeholders ask for changes to an FDA draft guidance on developing targeted therapies in low-frequency molecular subsets of a disease.
FDA sends a second complete response letter to Apricus Biosciences on its NDA for Vitaros (alprostadil topical cream) for treating erectile dysfunctio...
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.
The CDER Office of Prescription Drug Promotion cautions Collegium Pharmaceuticals about a misleading exhibit booth for Xtampza ER.