OTC Labeling and Advertising - Webinar CD/Transcript

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OTC Labeling and Advertising: Claims, Compliance and Avoiding Enforcement Action

What are the most significant new developments that marketers of OTC drugs face?

Stacy Erhlich and Will Woodlee — Partners at Kleinfed, Kaplan & Becker, LLC — will discuss what OTC drug products require premarket approval, labeling and promotion rules, and common but avoidable mistakes in marketing OTC drug products.

They will highlight areas of regulatory risk and the current enforcement priorities of the FDA, FTC and other regulatory bodies.

After listening to this session you will know:

  • How the FDA determines whether the agency will regulate a product as a drug and whether the drug must be dispensed only with a health care provider’s prescription?
  • Which OTC drugs require prior approval from FDA
  • The difference between OTC drug labeling and advertising, and who regulates the content of these materials
  • What needs to appear on OTC drug labeling and the common mistakes made by industry
  • The current FDA and FTC enforcement trends

Avoid the common mistakes in marketing OTC drug products. Order today.

  • Regulatory Affairs
  • Quality Assurance
  • Marketing Professionals
  • Attorneys
  • Consultants

Meet Your Presenters

Stacy Ehrlich, Partner, Kleinfeld, Kaplan & Becker, LLP
Stacy Ehrlich’s law practice focuses on counseling and advocating on behalf of pharmaceutical, food, dietary supplement, tobacco, cosmetic, and medical device companies on a variety of matters involving FDA, USDA, and FTC, as well as state agencies. Ms. Ehrlich has substantial expertise with regard to product approvals, labeling and promotion, OTC switches, food safety and ingredients, and corporate due diligence matters.

Will Woodlee, Partner, Kleinfeld, Kaplan & Becker, LLP
Will Woodlee’s practice focuses primarily on counseling and advocating on behalf of food, dietary supplement, cosmetic, pharmaceutical, medical device, tobacco, and consumer product companies on regulatory and advertising law matters.