Federal Register notice: FDA reopens the comment period for a 6/1/2018 notice on a shared system risk evaluation and mitigation strategy draft guidanc...
Federal Register notice: CDER lists certain meetings from 3/10 through 4/30 that are postponed, canceled, or modified to take place remotely.
Politico says FDA is turning to Twitter to request information on Covid-19 testing supplies from medical device manufacturers.
FDA approves changes to Gileads Epclusa labeling to include specific pediatric use.
Three stakeholders suggest changes to an FDA draft guidance on demonstrating substantial evidence of effectiveness for human drug and biological produ...
FDA commissioner Stephen Hahn says that FDA is looking at repurposing older drugs to treat or prevent coronavirus.
FDA warns Invigtrx Therapeutics about 17 deficiencies in its processing of products for allogeneic use.