FDA commissioner Robert Califf and Oncology Center of Excellence director Richard Pazdur endorse a return of FDA employees to the White Oak, MD headqu...
An Insulet recall of its Omnipod DASH Insulin Management System receives a Class 1 recall classification by FDA.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for use by ANDA sponsors.
Two FDA information technology executives describe the agencys new cybersecurity modernization action plan.
Federal Register notice: FDA announces its preliminary assessment that certain types of naloxone hydrochloride drug products may be approvable as safe...
Academic medical center researchers worldwide call on FDA to pause its approval of Biogens Aduhelm to treat Alzheimers disease while it investigates t...
Attorney Steven Boranian praises a California Court of Appeal decision invoking federal preemption in a failure-to-warn case involving the heart drug ...
FDA denies two Informed Consent Action Network petitions seeking agency action to modify emergency use authorizations for Covid-19 vaccines.
