February 11, 2015
FoREMS & More: An Update on REMS for Generic Drug Products
This webinar pertains to both innovator and generic drug manufacturers. ANDA regulations require that a generic drug be comparable to the innovator drug in dosage form, strength, route of administration quality, performance characteristics, and intended use. Performance is demonstrated through bioequivalence based on bioavailability. Under FDAAA 2007, if the innovator drug/reference listed drug (RLD) has a REMS with Elements to Assure Safe Use (ETASU) to ensure the benefits outweigh the risks, a drug subject to an ANDA is also subject to certain REMS elements, including ETASU, as applicable to the RLD. Manufacturers of generic drugs face some unique challenges in the current legislative and REMS environment, including Single Shared Systems. These challenges, along with an overview of the current REMS landscape, will be presented and will be informative for lifecycle considerations for innovator and generic drug manufacturers.
This webinar will provide an overview of:
- The evolving legislative environment
- Selected challenges for manufacturers of generic drug products
- The current REMS landscape for generic drug products
- What to watch for in 2015
Presenting this webinar:
- Regina L. Ruben, Ph.D. | Director, Clinical Consulting, ParagonRx
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