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

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

Never before have we seen this much attention focused on optimizing the regulation of combination products.

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. You 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 your rights and remedies are if you feel that your combination product is not being handled properly by the FDA

Order your copy of 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.

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