FDA launches a new resource for external and agency researchers collecting historical information about FDAs drug approvals.
Federal Register notice: FDA announces a 4/23-24 Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meeting.
FDA posts a revised guidance on drug application submissions that use electronic Common Technical Document specifications.
A drug supply chain security pilot program endorses blockchain technology to meet Drug Supply Chain and Security Act requirements for the U.S. pharmac...
Federal Register notice: FDA withdraws approval of 15 ANDAs from multiple applicants after notifying the agency that they are no longer marketed.
FDA approves a Flowonix Medical PMA for the Prometra II Programmable Pump System for an expanded use with intrathecal baclofen.
FDA clears a KinetiCor 510(k) for the KinetiCor Motion Correction System and its use with Siemens Magnetom Skyra 3T MRI scanner.
FDA issues a final rule and other documents in advance of the 3/23 transition of biological products from Federal Food, Drug, and Cosmetic Act approva...