Bringing a pharmaceutical product to market in the United States is one of the most sophisticated and demanding regulatory processes in the health industry. The Federal Food, Drug, and Cosmetic Act (FFDCA) and 21 CFR Parts 312 (IND), 314 (NDA/ANDA), and 600-680 (biologics) establish the framework, with FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) as the governing authorities.

This course builds deep competence in the requirements for bringing pharmaceutical products to market in the U.S. It covers the FFDCA and FDA framework, the drug development process (preclinical, IND-enabling, Phase I-III, NDA/BLA, and ANDA for generics), and post-market surveillance. Topics include drug labeling and packaging, advertising and promotion, pharmacovigilance and FAERS reporting, Risk Evaluation and Mitigation Strategies (REMS), and emerging accelerated pathways such as Breakthrough Therapy, Fast Track, Accelerated Approval, and Priority Review.