FDA’s Office of Combination Products - Webinar CD/Transcript

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FDA’s Office of Combination Products: Deciphering FDA’s Jurisdictional Determinations 

Deciphering combination products regulations is as difficult as ever.

What can you do to increase your chances of getting the classification you want?

Jennifer Newberger, Director, Hyman, Phelps & McNamara, P.C. discusses the expected outcomes of the recent FDA actions, and the impact of the FDA’s historical approach to classifying combination products.

You will learn:

  • Keys to drafting an RFD
  • Critical information to include in an RFD
  • The role of the newly established Combination Products Policy Council
  • Mechanisms for appeals

Order today and gain a better understanding of how to approach the FDA with a combination product.

  • Compliance personnel
  • Regulatory affairs professionals
  • QA/QC personnel
  • Manufacturing executives
  • 510(k) application specialists

Jennifer Newberger, Director, Hyman, Phelps & McNamara, P.C. 
Jennifer has worked with companies to draft, submit, and appeal decisions related to combination products, and to interact with FDA regarding jurisdictional determinations.