FDA sends Boehringer Ingelheim and Eli Lilly a complete response letter on a supplemental NDA New Drug Application (sNDA) for empagliflozin 2.5 mg and...
FDA Review has posted the Federal Register notices for the week ending 4/17/2020.
Federal Register notice: FDA makes available a final guidance entitled Required Warnings for Cigarette Packages and Advertisements: Small Entity Compl...
Federal Register notice: FDA issues a final rule to establish new health warnings for cigarette packages and advertisements.
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.