Three researchers could for steps outside the patent system to encourage discover of new uses for generic drugs.
FDA warns Chinas Hangzhou Facecare Cosmetics Co. about CGMP violations in its production of finished pharmaceuticals as a contract manufacturer.
Federal Register notice: FDA announces the names of the members who will serve on its Performance Review Board.
Federal Register notice: FDA provides notice that an applicant for a proposed biosimilar product notified the agency that a patent infringement action...
Simple Diagnostics recalls three lots of Pharmacist Choice Alcohol Prep Pads, which were manufactured by China-based Foshan Flying Medical Products, d...
Stakeholders give FDA general and specific comments on a draft guidance on statistical approaches to evaluating analytical similarity in biosimilars.
Medytox asks FDA not to approve an Evolus BLA for a neurotoxin product manufactured by Daewoong until the agency verifies the toxin strain that is in ...
European activists vow to end all dental amalgam use in the EU by 2022, in sharp contrast to FDAs continued defense of the device.