FDA Review posts the Federal Register notices for the week ending 5/14/2021.
Federal Register notice: FDA opens a public docket for comments on Evaluating the Clinical Pharmacology of Peptides.
Federal Register notice: FDA determines that Taro Pharmaceutical Industries Ovide (malathion) lotion, 0.5%, was not withdrawn due to safety or effecti...
Federal Register notice: FDA issues an order debarring Rick Shepard for five years from importing or offering for import any drug into the U.S.
Federal Register notice: FDA announces a 6/3-4 meeting of the Medical Devices Advisory Committees Neurological Devices Panel that will make classifica...
CDRH cybersecurity policy analyst Matthew Hazelett says the Center expects to release by the end of the year an updated draft guidance on medical devi...
Federal Register notice: FDA announces a 6/24 Oncologic Drugs Advisory Committee that will discuss an Incyte BLA for retifanlimab injection.
Biogen says its Phase 2/3 XIRIUS study of cotoretigene toliparvovec, a gene therapy being investigated for patients with X-linked retinitis pigmentosa...