FDAnews Announces — Combination Products and Cross-Center Reviews: Examining the Regulatory Pathway for Complex Products Under the 21st Century Cures Act Webinar, March 21

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The 21st Century Cures Act adds an extensive new set of statutory provisions intended to provide greater consistency in the FDA’s regulation of combination products and procedural remedies to ensure the optimal review of combination products. Join David M. Fox — Partner, Hogan Lovells — on March 21 for a close look at the FDA’s new authority governing combination products and several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA.

Combination Products and Cross-Center Reviews:
Examining the Regulatory Pathway for Complex Products
Under the 21st Century Cures Act
**An FDAnews Webinar**
March 21, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/crosscenter            

Mapping out a regulatory pathway for drug/device/biologic combination products remains one of the most difficult regulatory challenges for life sciences innovators.

The 21st Century Cures Act adds an extensive new set of statutory provisions intended to provide greater consistency in the FDA’s regulation of combination products and procedural remedies to ensure the optimal review of combination products.

Join David M. Fox — Partner, Hogan Lovells — on March 21 for a close look at the FDA’s new authority governing combination products and several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA.

After this 90-minute webinar attendees will know:

  • Which FDA Centers will take the lead on combination products under the 21st Century Cures Act
  • Whether the consulting Center will raise issues involving combination producst later in the development or review process — and what to do about it if they do
  • Whether FDA will apply a “least burdensome” approach or if manufacturers will have to do twice the usual amount of work
  • Why the Office of Combination Products may send a product to the drug Center when it was designed to be a device
  • What specific guidance is top priority for FDA as it regulates combination products under the 21st Century Cures Act

Register today and learn how to position products to ensure the least burdensome and the most optimal regulatory pathway.

Meet the Presenter:
David M. Fox, Partner, Hogan Lovells, former Associate Chief Counsel for Drugs and former counsel to the FDA’s combination products and product jurisdiction programs

David M. Fox is a leading authority on the regulation of prescription and over-the-counter drugs, biological products, combination products and controlled substances. David advises management teams, from start-ups to the largest global pharmaceutical and biotechnology companies and on matters before the FDA and DEA. He is closely integrated with funding sources for the industry and is frequently retained as a strategic advisor on assessing the value of life sciences assets. He is known for his collaborative approach to complex regulatory issues and has successfully resolved numerous differences between sponsors and staff at FDA on products that raise novel issues.

Who Will Benefit:

  • Regulatory affairs
  • Clinical
  • Legal

Webinar Details:
Combination Products and Cross-Center Reviews:
Examining the Regulatory Pathway for Complex Products
Under the 21st Century Cures Act
**An FDAnews Webinar**
March 21, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/crosscenter            

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/crosscenter                                        
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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