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
AveXis tells FDA it has terminated two senior executives who were the subject of a company investigation into data manipulation for its Zolgensma.
FDA approves a Cardiovascular Systems PMA for its ViperWire Advance Coronary Guide Wire with Flex Tip.
Federal Register notice: FDA makes available a final guidance entitled Amyotrophic Lateral Sclerosis (ALS): Developing Drugs for Treatment.