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...
Research into reporting of clinical trials shows that while FDA could have issued fines of more than $4 billion for companies that failed to report tr...
FDA principal deputy commissioner Amy Abernethy tells a Webinar that the agencys large-scale and ambitious plan to modernize its information technolog...
FDA says a Teleflex Medical recall of Comfort Flo humidification systems is Class 1.
FDA grants priority review to a BioMarin investigational gene therapy for hemophilia A.