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FDA Regulatory and Compliance Monthly Recap – November 2014

Key Findings in This Issue:

  • In an unusual move, the FDA takes issue with the accuracy of Sciecure’s studies in a warning letter over sales promotion material for the company’s sleeping pill
  • Office of Inspector General’s 2015 work plan shows agency will examine medical device security, FDA’s regulation
  • The Department of Health and Human Services proposes tougher reporting rules in a bid to increase clinical trial transparency
  • FDA proposes three studies on direct-to-consumer prescription drug ads in a bid to better understand the impact of ad exposure frequency, spousal influence and risk understanding