Product Details
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.