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Federal Register notice: FDA makes available a final guidance on nonbinding feedback after a medical device inspection.[ Price : $8.95]
FDA associate commissioner for minority health Richardae Araojo reviews progress made in the last years by the Office of Minority ...[ Price : $8.95]
FDA accepts for review a Mallinckrodt NDA for terlipressin, indicated for treating hepatorenal syndrome type 1.[ Price : $8.95]
FDA approves an Immunomedics BLA for Trodelvy (sacituzumab govitecan-hziy) for treating adult patients with triple-negative metast...[ Price : $8.95]
FDA posts a ventilator interactive review template for use by those seeking an emergency use authorization.[ Price : $8.95]
Three stakeholders suggest changes to an FDA revised draft guidance on nonclinical safety evaluation of drugs and biologics immuno...[ Price : $8.95]
Three stakeholders give general and specific comments on an FDA draft bridging guidance for combination products.[ Price : $8.95]
Former FDA commissioner Donald Kennedy (1977-1979) dies due to Covid-19 at the age of 88.