OTC Regulation - Webinar Recording/Transcript

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OTC Regulation: Latest Developments and Best Practices

There’s pending OTC monograph legislation in Congress that could result in significant changes in the OTC space. And, the FDA issued draft guidance on OTC innovation in 2018.

Christine Kirk — an associate in the Food and Drug Group of Arnall Golden Gregory’s healthcare practice — will discuss recent developments in OTC regulation and enforcement as well as key compliance topics. You’ll learn about:

  • Significant OTC monograph reform legislation that is currently pending in Congress (H.R. 269) which would:
    • Establish an OTC user fee program
    • Change the way that monographs are issued
    • Provide a pathway for limited exclusivity for certain OTC products
  • 2018 draft guidance on innovation in the OTC space published as Innovative Approaches for Nonprescription Drug Products which includes:
    • The development of labeling in addition to the DFL
    • The implementation of additional conditions so that consumers appropriately self-select and use the product
  • Recent OTC-related enforcement actions
  • Common areas of confusion — such as marketing claims and labeling requirements
  • Key compliance issues and resources

You’ll come away with a deeper understanding of the recent developments in the OTC area.

  • Regulatory
  • Legal
  • Compliance
  • Advertising and promotion

Christine Kirk is an associate in the Food and Drug Group within Arnall Golden Gregory’s Healthcare Practice, and focuses her regulatory compliance practice on food, drug, and device law. Ms. Kirk has several years of experience with FDA, where she worked in CDER’s Office of Regulatory Policy (ORP). While at FDA, Ms. Kirk worked on a wide variety of matters, including regulations, guidance, citizen petitions, and policy development. Ms. Kirk also has experience in reviewing comments on proposed regulations and guidance.