This episode dives into the complex world of U.S. regulations for clinical trials. Examine the detailed provisions within U.S. regulations for clinical trials as we explain how FDA guidance documents, relevant sections of 21 CFR, and associated Q&A documents shape current clinical practices. We will also break down enforcement strategies, such as inspection protocols, providing practical examples of regulatory interpretations to ensure adherence to cGCP requirements.

We'll discuss how the Bioresearch Monitoring Program (BiMo) oversees clinical trials through inspections and audits. This includes GCP inspections linked to NDA's and BLA's, good laboratory practice, bio equivalence studies, and the institutional review board. The listener will also come away with an understanding of those critical to quality factors. This allows the FDA to concentrate on key areas, when triggered, rather than the entire process.