AcelRx Pharmaceuticals, Inc.
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Latest From AcelRx Pharmaceuticals, Inc.
US FDA's staff have sometimes worked late into the night to help sponsors meet deadlines and avoid errors in responding to a notice of violation. As is often the case, early communication helps avoid problems.
Agency cites video promoting Biohaven’s Nurtec ODT, which first aired on ABC’s TV show The View, for misleading comparative claims, inadequate display of risk information, and failure to submit promo for review.
CooperSurgical is hit with second letter for misleading promotion of its copper-containing intrauterine contraceptive. Video lacked any safety information, agency says in request for corrective communication.
Pink Sheet reporters and editor discuss the issues surrounding an FDA warning letter on Dsuvia promotion, an expected jump in CDER coronavirus-related workload, and a study of refuse-to-file actions.
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