OTC Drug Safety, Innovation & Reform Act (S.2315)

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Thu, Nov 15, 2018
Length
60 minutes
Product Description

Mitigate the Risk of FDA Enforcement Action in the Future

 

The recently approved Over-the-Counter (OTC) Drug Safety, Innovation, and Reform Act, S.2315 will have a huge impact on all companies in the OTC drug industry. It proposes key reforms to the regulatory system that oversees the majority of OTC medicines – the OTC Monograph system. OTC drugs comprise approximately 60% of all medicines sold in the United States. If you develop and produce an OTC drug for marketing and sale in the U.S., you need to understand these changes so that you can mitigate the risk of enforcement action in the future.

Get a comprehensive understanding of the changes that the Act will bring, in this webinar with industry expert Norma Skolnik. Skolnik will walk you through the key changes, and discuss how they will impact the current and future OTC drug products you develop, produce and market in the United States. You will learn how the OTC Drug Monograph system will change under this Act; what specific products will be impacted; what labeling changes will be needed; and how the Act will affect future products that aren’t currently covered by existing OTC Monographs.

After attending this webinar, you’ll be better prepared to introduce new and innovative OTC drug products for marketing and sale in the United States, while mitigating the risk of FDA enforcement action in the future.

Session Highlights

You will learn:

  • About the changes to the OTC Reform Act
  • How the OTC Reform Act will impact companies in the OTC drug industry
  • How the changes to the OTC Monograph system will impact you
  • How the OTC Reform Act will help you to introduce new and innovative products
  • How the OTC Reform Act will impact your current and future OTC drug products
  • What specific products will be impacted and what labeling changes will be needed
  • How the OTC Reform Act will affect future products that aren’t currently covered by existing OTC Monographs

Who Should Attend

  • Regulatory affairs managers, directors and associates
  • Legal representatives
  • R&D managers
  • Consumer healthcare professionals

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Norma Skolnik - FDA Regulations Expert

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that, she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company. She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare and...   More Info
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