Regulatory Roundup: FDA Provides Online Course on its Drug-Regulation Activities

Jul 01, 2010
By PharmTech Editors

The US Food and Drug Administration's website now features a free online 90-minute training program on the “Past, Present, and Future of FDA Human Drug Regulation.” The mini web-seminar provides an overview of the agency’s activities, starting with why FDA was established. The course includes a series of information slides, audio presentations, and brief polling questions. At the end of the session, users can take a test to receive a continuing education (CE) certificate or a certificate of completion (non-CE). The online course covers the steps required to develop and market a new drug (as well as OTC, generic, and fast-track drugs), the role of the Center for Drug Evaluation and Research, and the Office of Generic Drugs, patents and market exclusivity, compliance and postapproval monitoring, and recent FDA initiatives such as the Sentinel System, the Critical Path initiative, emergency relief, and harmonization. The goal is to help physicians, industry, patients, healthcare providers, and consumers better understand FDA and its activities.