Federal Register notice: FDA seeks comments on a proposal to make permanent certain medical device regulatory flexibilities provided during the Covid-...
Federal Register notice: HHS requires FDA to publish annually on its Web site certain NDA/ANDA review tracking information.
FDA gives conditional approval to Pegasus Laboratories KBroVet-CA1 to treat idiopathic epilepsy in dogs.
FDA clears a Hyperfine Research 510(k) for its deep-learning image analysis software to measure brain structure and pathology in images acquired by th...
Three FDA staffers give an update on the agencys position on paclitaxel-coated devices used to treat peripheral arterial disease.
FDA issues an immediately effective guidance to help sponsors develop monoclonal antibodies and other therapeutic proteins for treating Covid-19.
FDA issues a report summarizing its Pandemic Recovery and Preparedness Plan Initiative work in the second half of 2020.
FDA releases minutes and meeting summaries for five PDUFA 7 negotiation meetings at the end of 2020.