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FDA approves a Thermo Fisher Scientific PMA for its Oncomine Dx Target Test as a companion diagnostic to help identify non-small c...[ Price : $8.95]
FDA warns Chicago-based Synaptent it is marketing unapproved and misbranded new drugs as dietary supplements.[ Price : $8.95]
FDA releases the FDA-483 with eight observations issued following an inspection at a Dr. Reddys sterile drug manufacturing facilit...[ Price : $8.95]
Departing FDA interim commissioner Janet Woodcock identifies some priorities she hopes incoming commissioner Robert Califf will co...[ Price : $8.95]
Federal Register notice: FDA draft guidance provides IND clinical recommendations for Individualized Antisense Oligonucleotide Dru...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled IND Submissions for Individualized Antisense Oligonucleotid...[ Price : $8.95]
Pfizer says it will submit full Paxlovid anti-Covid trial data to FDA in a few days.[ Price : $8.95]
FDA publishes an updated Clinical Outcome Assessment Compendium.