FDA touts the 10th anniversary of the CDRH cybersecurity program, highlighting several program achievements.
Reps. Bucshon and DeGette call on Congress to pass the VALID Act in response to FDAs proposed rule on laboratory-developed tests.
FDA grants Invitae a de novo market authorization for its Common Hereditary Cancers Panel for identifying germline variants associated with hereditary...
Federal Register notice: FDA is announcing an 11/7 Radiological Devices Panel of the Medical Devices Advisory Committee meeting to discuss proposed cl...
Federal Register notice: FDA announces the revocation of 11 Covid-related Emergency Use Authorizations after the authorization holders requested they ...
Federal Register notice: FDA releases a draft guidance entitled Stimulant Use Disorders: Developing Drugs for Treatment.
CBS News says a drug supply chain association issued an alert that FDA is investigating counterfeit Ozempic.
CDER says its NextGen Portal is now accepting Over-the-Counter Monograph Order Requests.
