FDA releases the FDA-483 with seven observations from an inspection at a Lilly sterile drug manufacturing facility.
FDA posts a Web page with answers to common questions on medical device online 506J notification submission methods during the Covid-19 pandemic.
The Justice Department says Alere and its Arriva subsidiary are paying $160 million to resolve False Claims Act charges first brought by a whistleblow...
Bristol Myers Squibb decides to withdraw a 2011 indication granted to subsidiary Celgene under accelerated approval for Istodax (romidepsin), a histon...
FDA warns Farmakeio Outsourcing about violations at its Texas drug facility.
FDA accepts a Genentech sBLA for a new indication for Tecentriq and grants it priority review.
Philips Respironics recalls its V60 and V60 Plus ventilators that provide High Flow Therapy, due to a risk to the patients if the system pressure reac...
Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Device Recall Authority--21 CFR Part 810.