Lead Pharmacologist
U.S. Food and Drug Administration
Silver Spring, Maryland
Dr. Josephine Aimiuwu is a Lead Pharmacologist in the Division of Bioequivalence II (DB II), Office of Bioequivalence (OB), Office of Generic Drug (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). In this role, Dr. Aimiuwu lead a team of assessors and perform secondary assessment of the bioequivalence portion of Abbreviated New Drug Applications (ANDAs) and post-approval supplements to support Generic Drug development as well as engaging in the Pre-ANDA meeting program as part of GDUFA. She has experience evaluating in vivo and in vitro bioequivalence studies for various dosage forms such as immediate/modified release formulations, topical dermatological, complex ophthalmic, narrow therapeutic, vaginal drug products and abuse deterrent formulations. Dr. Aimiuwu stepped away from the U.S. FDA for four years and gained experience in global regulatory framework with USAID-funded Non-Governmental Organizations to leverage resources with consortia of global partners to strengthen and provide technical support to the Generic Drug Regulatory Program in Bangladesh and Nigeria while living abroad. Dr. Aimiuwu obtained her Bachelors in Pharmaceutical Sciences and PhD in Pharmaceutics from The Ohio State University, Columbus, Ohio.
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Speaker Spotlight: Patient-Focused Drug Development: CMC Considerations
Wednesday, October 23, 2024
11:30 AM – 12:30 PM MT