CDER Office of Compliance director Donald Ashley tells a Food and Drug Law Institute conference that FDA is continuing to explore using remote regulat...
Biogen agrees to pay $22 million to resolve allegations that it violated the False Claims Act by illegally using two foundations as conduits to pay Me...
Federal Register notice: FDA sends to OMB an information collection extension for Application for Participation in FDA Fellowship and Traineeship Prog...
Federal Register notice: FDA proposes to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to ...
FDA issues an Emergency Use Authorization (EUA) for Modernas Covid-19 vaccine for use in individuals 18 years of age and older.
Federal Register notice: FDA makes available a final guidance entitled Controlled Correspondence Related to Generic Drug Development.
Federal Register notice: FDA makes available a draft guidance entitled Dry Eye: Developing Drugs for Treatment.
FDA posts the latest six-month update of its list of off-patent, off-exclusivity drugs without approved generics.