Division of Clinical Research

Office of the Vice President and Innovation

CE Credit Available

Presented by:
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.

Register here: https://collaborationcqpub1.fda.gov/content/connect/c1/7/en/events/event/shared/default_template/event_registration.html?sco-id=215791283&charset=utf-8

Categories FDA Regulatory, Uncategorized
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