FDA issues a temporary guidance entitled Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency to he...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dyax Corp.s Takhzyro, indicated for prophylaxis...
FDA says it will soon issue a guidance for sponsors to request an Emergency Use Authorization for their vaccines, including recommendations on the dat...
FDA issues Pharmacy Plus (dba Vital Care Compounder) a Warning Letter for offering unapproved drug products for prophylaxis and treatment of, and reco...
CBER sends an untitled letter to Laguna Beach Aesthetics, Cosmetic Dermatology and Laser Center over its unapproved cellular product derived from adip...
RLC Labs recalls 483 lots of Nature-Throid and WP Thyroid because FDA testing of samples from six lots found them to be subpotent.
FDA clears an Avinger 510(k) for its TigerEye image-guided chronic total occlusion crossing system.
FDA holds a Webinar to explain the de novo pathway for use with new neurological and physical medicine devices.