FDAnews Announces — FDA’s Office of Combination Products: Deciphering FDA’s Jurisdictional Determinations Webinar, Aug. 11, 2016

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How will the new Combination Products Council affect the FDA’s actions? Join Jennifer Newberger, Director, Hyman, Phelps & McNamara, P.C. on Aug. 11 for a 90-minute webinar where she’ll discuss the expected outcomes of recent FDA actions, and the impact of the FDA’s historical approach to classifying combination products.

FDA’s Office of Combination Products
Deciphering FDA’s Jurisdictional Determinations
**An FDAnews Webinar**
Aug. 11, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/fdasofficecombinationproducts    

What’s going on with the new Combination Products Council? What is its role? How will it affect the FDA’s actions?

Join Jennifer Newberger, Director, Hyman, Phelps & McNamara, P.C. on Aug. 11 for a 90-minute webinar where she’ll discuss the expected outcomes of recent FDA actions, and the impact of the FDA’s historical approach to classifying combination products.

After this webinar attendees will know how to:

  • Submit a Request for Determination (RFD) that includes the information that FDA is really looking for to make the jurisdictional determination wanted
  • Increase the chances of having a determination that a product is a drug instead of a device, or vice-versa
  • Understand the real role of the new Combination Product Council and how this entity will affect agency actions
  • Develop the most effective appeal, if the RFD is denied
  • Comply with the final rule on cGMP requirements for single-entity combination products or constituent parts of a combination product, which involve completely different requirements
  • Comply with new guidance from FDA on post-approval modification of combination products and make sure the supplementary application meets agency expectations

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

Meet the Presenter:
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.

Who Will Benefit:

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

Webinar Details:
FDA’s Office of Combination Products
Deciphering FDA’s Jurisdictional Determinations
Aug. 11, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/fdasofficecombinationproducts    

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/fdasofficecombinationproducts            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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