FDA approves a Thermo Fisher Scientific PMA for its Oncomine Dx Target Test as a companion diagnostic to help identify non-small cell lung cancer pati...
FDA warns Chicago-based Synaptent it is marketing unapproved and misbranded new drugs as dietary supplements.
FDA releases the FDA-483 with eight observations issued following an inspection at a Dr. Reddys sterile drug manufacturing facility in India.
Departing FDA interim commissioner Janet Woodcock identifies some priorities she hopes incoming commissioner Robert Califf will continue pursuing.
Federal Register notice: FDA draft guidance provides IND clinical recommendations for Individualized Antisense Oligonucleotide Drug Products.
Federal Register notice: FDA makes available a draft guidance entitled IND Submissions for Individualized Antisense Oligonucleotide Drug Products for ...
Pfizer says it will submit full Paxlovid anti-Covid trial data to FDA in a few days.
FDA publishes an updated Clinical Outcome Assessment Compendium.