CDRH director Jeff Shuren says two important lessons learned during the Covid-19 emergency that CDRH envisions continuing long after the pandemic ends...
An FDA Notice of Violation says The Regen Centers is marketing unapproved cellular products and exosomes.
The House Energy and Commerce Committee asks FDA acting commissioner Janet Woodcock what the agency intends to do about delayed drug manufacturing fac...
FDA issues a finalized question-and-answer guidance on submitting field alert reports.
FDA places a clinical hold on a Magenta Therapeutics Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia and myelodysplastic ...
Vero Biotech recalls its Genosyl DS; Nitric Oxide Delivery System due to a software issue that leads to errors in gas delivery.
FDA acting commissioner Janet Woodcock discusses new agency plans to better secure the medical device supply chain.
The CBER Office of Compliance and Biologics Quality cautions The Dahlia Center that it is marketing unapproved cellular products.