Federal Register notice: FDA announces an 11/14 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss an Amarin Pharma supplemental...
Bloomberg Businessweek takes a lengthy review of the FDA involvement in the case of contaminated valsartan and other hypertension drugs.
A CNN opinion column calls for patent reform as a means of helping to address high drug prices.
CDER director Janet Woodcock challenges medical researchers to change the system in ways that will help bring more drugs to more patients.
FDA asks the Allergenic Products Advisory Committee to comment on whether efficacy and safety data support approval of Aimmune Therapeutics Palforzia ...
Federal Register notice: FDA determines that Sanofi Aventis Calcimar (calcitonin salmon) injection, 200 IU/mL was not withdrawn from sale due to safet...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Tsunami MedTechs Aegea Vapor System, indicated ...
Four stakeholders suggest changes to an FDA draft guidance on the format and content of instructions for use information for drugs, biologics, and com...