FDAnews Announces — New Management Report — Drug or Device? How the 21st Century Cures Act Impacts Combination Products

FDAnews

Drug or Device? How the 21st Century Cures Act Impacts Combination Products

**An FDAnews Management Report**

http://www.fdanews.com/drugordevice    

Combination products remain one of the most difficult regulatory challenges for life sciences innovators.

Which FDA Center has the lead?

Will the product need one marketing application or two?

Will a drug need to be cross-labeled and approved for use with a device?

These and many more questions can make combination product sponsors feel like they are entering an unforgiving regulatory labyrinth.

The 21st Century Cures Act requires the FDA, over the next several years, to issue guidance that will create a structured process and best practices for managing the development and reviews of drug/device/biologic combinations. The law provides for a streamlined approach to GMP for combination products similar to what the agency has recently announced through rule and guidance.

Drug or Device? How the 21st Century Cures Act Impacts Combination Products takes a close look at the FDA’s new authority governing combination products, as well as several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. Readers will learn:


  •     How the 21st Century Cures Act defines primary mode of action
  •     How to use pre-RFD (Request for Designation) meetings with the FDA to hammer out a customized review process that meets the sponsor’s needs
  •     How the FDA will determine which center (CDER, CDRH, CBER) will take the lead on reviewing combination product applications
  •     Whether FDA will apply a “least burdensome” approach or require sponsors to undertake twice the usual amount of work
  •     What a manufacturers rights and remedies are if they feel that their combination product is not being handled properly by the FDA

Order Drug or Device? How the 21st Century Cures Act Impacts Combination Products for practical advice on the newest changes in the law on combination products and a look around the corner at how sponsors of combination products should seek to position their products to ensure a least burdensome and optimal regulatory pathway.

Who Will Benefit:

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