FDA clears a Viz.ai 510(k) for the Viz Aneurysm module and its use on the Viz Intelligent Care Coordination Platform for detecting suspected cerebral ...
FDA extends its review of a United Therapeutics NDA resubmission for Tyvaso DPI (inhaled treprostinil) after receiving an information request letter f...
Federal Register notice: FDA announces a 3/22 virtual public meeting on the biosimilar user fee programs enhanced review transparency.
CDER Office of Prescription Drug Promotion senior social science research analyst Katherine Aikin explains the work her unit does on patient-level ind...
The CDER Office of Pharmaceutical Quality reports on its 2021 core function activities and efforts to carry out White House recommendations for improv...
Federal Register notice: FDA makes available a final guidance entitled Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints A...
AdvaMed comments on an FDA proposed information collection to prepare transition plans for some medical devices after the Covid-19 health emergency en...
FDA issues a second complete response letter in less than 18 months to Mallinckrodt for its NDA for terlipressin to treat adults with hepatorenal synd...