Federal Register notices: FDA issues two orders debarring Linda Godding and Mark Godding for five years from importing or offering for import any drug...
FDA lifts a clinical hold against Astellas Pharma and its FORTIS Ph1/2 clinical trial evaluating AT845, an adeno-associated virus gene replacement the...
The International Conference on Harmonization posts a final guide entitled Quality Risk Management Q9 (R1), which has been adopted by FDA for implemen...
Federal Register notice: FDA seeks comments on an information collection extension entitled Accreditation Scheme for Conformity Assessment Program.
The agency is seeking public comment on the guidance for 60 days.
FDA says a Surmodics PMA for its SurVeil drug-coated balloon to treat peripheral artery disease is not currently approvable.
FDA publishes a final rule amending and repealing some radiological health regulations.
FDA posts a draft guidance entitled Mpox: Development of Drugs and Biological Products.
