Understanding the Regulatory Requirements for the Over the Counter (OTC) Drugs in the US

Recorded Webinar | David Lim | From: Aug 01, 2017 - To: Sep 30, 2017
  • All drugs are reviewed and approved by the the FDA’s Center for Drug Evaluation and Research (CDER) before they can be consumed and used for human treatments. In as much as prescription drugs undergo heavy scrutiny, the same goes for over-the-counter drugs also known as non-prescription drugs.
  • In order to introduce OTC drugs within the US market, there is need for deep understanding of the rules and regulations that govern drug production. This webinar conference is designed to help you develop a complete understanding of how OTC nonprescription drugs are developed and brought into the US market.

Area covered in the session :

  • All laws and regulation pathways that regulate and govern OTC drugs in the US
  • Key points in OTC drug development
  • Requirements for OTC drug approval and consideration
  • FDA actions during drug review
  • OTC monographs
  • FDA and FTC jurisdictions
  • Recommendations for successful drug approval

Who will benefit ?

  • CEO and managers
  • Compliance officers
  • Drug regulators and developers
  • Clinical officers
  • Attorneys
  • Consultants
  • Healthcare personnel

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Recorded Session   +   $198
DVD   +   $208
Recorded Session & DVD   +   $328
Transcript (Pdf)   +   $178
Recorded & Transcript (Pdf)   +   $298
DVD & Transcript (Pdf)   +   $308

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