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FDA publishes two draft guidances revising previous Drug Supply Chain Security Act guidances.[ Price : $8.95]
FDA warns five companies that they are illegally distributing kratom products that are unapproved new drugs.[ Price : $8.95]
FDA lifts its clinical hold on Vertex Pharmaceuticals VX-880 stem cell therapy for type 1 diabetes.[ Price : $8.95]
FDA declines to approve an emergency use authorization for NRx Pharmaceuticals Zyesami in some critical Covid-19 patients.[ Price : $8.95]
The FDA Peripheral and Central Nervous System Drugs Advisory Committee meets on 9/7 to consider new information from Amylyx on its...[ Price : $8.95]
FDA lists enhancements to the CDRH electronic medical device reporting system and sets a schedule for future changes.[ Price : $8.95]
Federal Register notice: FDA corrects the docket number associated with a 6/30 notice on a draft guidance entitled Patient-Focused...[ Price : $8.95]
UK researchers say genetic evidence supports two-thirds of drugs FDA approved in 2021.