The ICH says the Medical Dictionary for Regulatory Activities is being updated to standardize coding of the coronavirus.
FDA releases the FDA-483 with 10 inspection observations from an inspection of Immunomedics, Inc.
FDA gives Vanda Pharmaceuticals approval to begin a clinical study of tradipitant in hospitalized patients with Covid-19-related pneumonia.
FDA warns dietary supplement manufacturer Bulletproof 360 about CGMP and new and misbranded drug violations.
FDA warns Steiner Biotechnology about violations in its conduct of nonclinical laboratory studies.
FDA proposes to reclassify two types of hepatitis C diagnostic tests from Class 3 to Class 2 with special controls.
Federal Register notice: FDA amends certain medical device regulations to accurately reflect the devices exempted from premarket notification (510(k))...
FDA asks manufacturers of all Rx and OTC ranitidine products to remove them from the market due to NDMA contamination.