Simplifying Global Compliance
Combination Products and Cross-Center Reviews - Webinar CD/Transcript
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Combination Products and Cross-Center Reviews: Examining the Regulatory Pathway for Complex Products Under the 21st Century Cures Act
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 and Robert Church — Partners, Hogan Lovells — 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 session you’ll 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 your combination product 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 you will have to do twice the usual amount of work
- Whether you will need a drug to be cross-labeled and approved for use with your device
- Why the Office of Combination Products may send your product to the drug Center when you designed it to be a device
- What your rights and remedies are if you feel that your combination product is not being handled properly by FDA
- What specific guidance is top priority for FDA as it regulates combination products under the 21st Century Cures Act
Order today and learn how to position your products to ensure the least burdensome and the most optimal regulatory pathway.
- Regulatory affairs
- Clinical
- Legal
Meet Your Presenters
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.
Robert Church, Partner, Hogan Lovells
Rob Church brings a wealth of knowledge and experience to his pharmaceutical and biotechnology regulatory law practice, having previously served as an Associate Chief Counsel at the Food and Drug Administration (FDA), and in senior positions at Amgen Inc. At the FDA, Rob's practice was focused on the regulation of all aspects of the pharmaceutical industry, with particular emphasis on clinical trials, drug development, and new product approvals. At Amgen, Rob served as associate general counsel and the company's lead FDA lawyer. During his last three years at the company, Rob was the head of Amgen's Global Research and Development Compliance Department where he had oversight responsibility for all quality assurance, audit, and compliance activities within Amgen's R&D operations.