Federal Register notice: FDA issues a final rule to provide additional information on the content and format of reports intended to demonstrate substa...
FDA defers a review action on GlaxoSmithKlines PD-1 drug dostarlimab, indicated for treating endometrial cancer, because it could not conduct a manufa...
A Vanity Fair special report examines how former FDA commissioner Stephen Hahn became the most politicized commissioner in recent history and describe...
FDA clears an Eitan Medical 510(k) for its upgraded Sapphire infusion pump system and software Rev15, which includes pump, administration sets and acc...
L.E.K. consulting says better product launches are a key to profits in drug development over the last 15 years.
Outgoing FDA commissioner Stephen Hahn says the agency does not support a last-minute policy restriction placed on FDA involving animal genetic engine...
Federal Register notice: FDA sends to OMB an information collection extension entitled Data to Support Drug Product Communications as Used by the Food...
Three University of Pennsylvania medical school health policy experts propose a way to keep necessary political involvement in FDA decisions from inte...