CDERs Office of Prescription Drug Promotion warns Vanda about a Web page promoting its Fanapt and Hetlioz that doesnt contain any risk information abo...
FDA approves Mercks Keytruda in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with met...
Federal Register notice: FDA makes available a draft guidance entitled Considerations for the Development of Dried Plasma Products Intended for Transf...
Federal Register notice: FDA withdraws approval of 10 NDAs from multiple applicants after they notified the agency that the drug products were no long...
FDA posts details of an Accreditation Scheme for Conformity Assessment (ASCA) pilot program that aims to enhance the predictability of the medical dev...
An FDA analysis says more ANDAs could be approved in the first cycle if sponsors ensured their applications were complete at the time of filing.
FDA medical reviewers raise questions about several aspects of an Alkermes NDA for a combination drug to treat major depressive disorder.
FDA commissioner Scott Gottlieb introduces a new Plant and Animal Biotechnology Innovation Action Plan to help ensure the safety of plant and animal b...