The Speeding Access to Already Approved Pharmaceuticals Act of 2014 would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union
Parent Project Muscular Dystrophy (PPMD) and allied stakeholders recently gave FDA the first patient advocacy-initiated guidance for a rare disease to help accelerate development and review of potential therapies for Duchenne muscular dystrophy.
Months before FDA's expected main venture this summer into regulating medical marketers' activities in social media, the industry reacted sharply to a draft guidance the agency issued in January
A Manhattan Institute analysis says that helping underperforming FDA drug review divisions match the output of high-performing divisions could cut development costs and speed approval of new treatments.
Nineteen Republicans on the House Energy and Commerce Committee want FDA commissioner Margaret Hamburg to explain the role the American Association for Justice (trial lawyers) played in drafting proposed changes to generic drug labeling.