FDA Review posts the Federal Register notices for the week ending 8/21/2018.
FDA releases a new draft guidance that is intended to modernize clinical trial designs in oncology drug development.
Federal Register notice: FDA announces a 9/10 public workshop entitled Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utilit...
FDA approves an Alnylam Pharmaceuticals NDA for Onpattro (patisiran) infusion for treating peripheral nerve disease caused by hereditary transthyretin...
Federal Register notice: FDA submits to OMB a new information collection study entitled Disclosures in Professional and Consumer Prescription Drug Pro...
FDA approves a Population Council NDA for Annovera, first vaginal ring contraceptive that can be used for an entire year.
Spacelabs Healthcare recalls the Arkon Anesthesia Delivery System due to the device going into a failed state, which causes the mechanical ventilation...
Vyaire Medical recalls its AirLife Resuscitation Device due to a manufacturing error.