Falls Church, VA (PRWEB)
June 30, 2017
Drug or Device? How the 21st Century Cures Act Impacts Combination Products
**An FDAnews Management Report**
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: