Synchrocast Ep 3: FDA Scrutiny Around ENDS Products

Synchrogenix's Darshan Kulkarni, Vice President, Regulatory Strategy and Policy, and Evan Richardson, Director, Regulatory Services talk about the recent FDA scrutiny around electronic nicotine delivery system (ENDS) products in this episode of Synchrocast. Evan oversees our work preparing regulatory submissions to the Center for Tobacco Products. Listen to learn more about how the FDA is attempting to crack down on the use of ENDS products by minors, and what companies should be considering in order to avoid FDA scrutiny moving forward.

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Synchrogenix offers an end-to-end solution to companies seeking regulatory approval for "reduced risk" claims, premarket review, and nicotine replacement therapy, including:

  • Consulting, authoring, and submission services
  • PMTA/MRTPA Templates
  • Project scope and content planning
  • Regulatory strategy and operational consulting
  • Submission leadership
  • Document authoring and formatting
  • Publication of submission documents

Please visit Synchrogenix's GlobalSubmit website to learn more about these offerings.

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