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Federal Register notice: FDA extends the comment period for a 6/24 notice on a draft guidance entitled Remanufacturing of Medical ...[ Price : $8.95]
FDA says it has joined several additional medical device collaborative communities.[ Price : $8.95]
FDA grants PharmaTher Holdings an orphan drug designation for ketamine and its use in treating amyotrophic lateral sclerosis.[ Price : $8.95]
The Bloomberg editorial board calls on FDA to communicate transparently on the timing for final approval of Covid-19 vaccines that...[ Price : $8.95]
FDA releases the FDA-483 with seven observations from an inspection at a Lilly sterile drug manufacturing facility.[ Price : $8.95]
FDA posts a Web page with answers to common questions on medical device online 506J notification submission methods during the Cov...[ Price : $8.95]
The Justice Department says Alere and its Arriva subsidiary are paying $160 million to resolve False Claims Act charges first brou...[ Price : $8.95]
Bristol Myers Squibb decides to withdraw a 2011 indication granted to subsidiary Celgene under accelerated approval for Istodax (r...