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AcelRx Pharmaceuticals, Inc.

https://www.acelrx.com/

Latest From AcelRx Pharmaceuticals, Inc.

Responding To Rx Drug Promo Violations: Tips From OPDP

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.

Advertising, Marketing & Sales Enforcement

Keeping Up With the Kardashians: US FDA Objects To Khloé’s Migraine Drug Promo

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.

Ad Complaints Advertising, Marketing & Sales

US FDA’s ‘Bad Ad’ Program Snares Paragard Contraceptive TV Video Promo

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.

Ad Complaints Advertising, Marketing & Sales

Pink Sheet Podcast: Dsuvia Warning Letter, Refuse-To-File Impact, CDER’s COVID Workload

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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  • Industry
  • Pharmaceuticals
    • Specialty Pharmaceuticals
    • Drug Delivery
      • Controlled Release
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