The White House says President Trump has signed an executive order intended to modernize flu vaccines and help protect more Americans through vaccinat...
FDA updates its preliminary list of approved NDAs that will be considered BLAs as of 3/23/20.
Federal Register notice: FDA makes available a final guidance entitled Wholesale Distributor Verification Requirement for Saleable Returned Drug Produ...
Federal Register notice: FDA seeks comments related to post-marketing pediatric-focused safety reviews of products posted between 4/12 and 9/23 on the...
Federal Register notice: FDA announces a 10/29 advisory committee meeting to review an Amag Pharma confirmatory clinical trial that did not meet its c...
CDER issues a MAPP with procedures to be followed when its Division of Medication Error Prevention consults its Division of Medical Policy Programs fo...
FDA warns Nutra Solutions about CGMP violations in its work as a contract manufacturer of dietary supplements.
FTC warns seven unidentified legal practitioners and lead generators that TV ads soliciting clients to sue drug companies may be deceptive or