Federal Register notice: FDA extends the comment period for a 6/24 notice on a draft guidance entitled Remanufacturing of Medical Devices.
FDA says it has joined several additional medical device collaborative communities.
FDA grants PharmaTher Holdings an orphan drug designation for ketamine and its use in treating amyotrophic lateral sclerosis.
The Bloomberg editorial board calls on FDA to communicate transparently on the timing for final approval of Covid-19 vaccines that have emergency use ...
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...