FDA Grand Rounds – October 8, 2020
CE Credit Available
Sam Raney, PhD
Lead for Topical and Transdermal Drug Products
Office of Generic Drugs, CDER, FDA
About the Presentation:
This presentation summarizes a series of FDA-coordinated, GDUFA-funded research studies included in a strategic multi-year, multi-million dollar research program to develop new, more efficient approaches by which to evaluate bioequivalence (BE) for topical generics. These studies characterize solution, gel, ointment, lotion and cream topical products containing a range of drugs including acyclovir, metronidazole, nystatin, triamcinolone acetonide, lidocaine, prilocaine, and diclofenac.