FDA Review posts the Federal Register notice for the week ending 3/19/2021.
FDA announces a 5/4 virtual public meeting entitled Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices.
FDA accepts a Bristol Myers Squibb NDA for mavacamten, an investigational allosteric modulator of cardiac myosin for treating patients with symptomati...
CBERs Office of Compliance and Biologics Quality sends Reno Integrative Medical Center an untitled letter after reviewing the institutions Web site an...
An FDA safety alert advises that health care professionals not use Becton, Dickinsons ChloraPrep 3 mL applicators due to microbial contamination risks...
Federal Register notice: HHS postpones, pending judicial review, the effective date of a final rule entitled Securing Updated and Necessary Statutory ...
FDA approves a Janssen NDA for Ponvory (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor modulator for treating adults with re...
FDA approves a Kiniksa Pharmaceuticals NDA for Arcalyst (rilonacept) injection to treat recurrent pericarditis in adults and children 12 years and old...