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...
Outgoing FDA commissioner Stephen Hahn says he was under significant White House pressure on Covid vaccines and treatments.
FDA issues an immediately effective guidance on methanol testing in drug products during the Covid-19 public health emergency.
Federal Register Final Rule: HHS issues a final rule under the Regulatory Flexibility Act that requires agencies like FDA to publish plans to conduct ...