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FDA Regulatory and Compliance Monthly Recap - September 2014

Key Findings in this Issue:

  • FDA sends warning letters to companies who made claims on social media that their products treat, cure Ebola, marking the first time the Agency singles out Pinterest
  • OIG issues special advisory bulletin and report emphasizing prohibition on copay coupons for Federally reimbursable medications (including Part D covered drugs), notes potential anti-kickback violations
  • CMS rolls out Open Payments in effort to increase transparency and accountability