CDER plans to review and discuss its proposed Quality Management Maturity program at an 11/2 advisory committee meeting.
FDA issues a safety alert on autoinjector devices that are optional for use with multiple sclerosis therapy glatiramer acetate injection drug products...
FDA issues Pharvaris a clinical hold on two clinical trials of its PHA121, an oral bradykini B2-receptor antagonist for treating and preventing heredi...
FDA releases a revised draft guidance entitled Charging for Investigational Drugs Under an IND: Questions and Answers.
FDA clears a Koag 510(k) for its Vascette HP device, a topical vascular closure pad that uses a proprietary, plant-derived hemostatic foam.
Pfizer and BioNTech file a submission seeking FDA Emergency Use Authorization for their booster dose of an Omicron BA.4/BA.5-adapted bivalent Covid-19...
After 38 years as National Institute of Allergy and Infectious Diseases (NIAID) director, Anthony Fauci says he will be stepping down at the end of th...
Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Devices: Current Good Manufacturing Practice Quali...
