Activity Outline
Description: This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students, to provide better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety. This webinar will provide an overview of the development and federal regulations for vaccines in the United States. We will discuss key statutes that grants the Food and Drug Administration authority to regulate vaccines, precipitating historical events, and current regulatory requirements for vaccine licensure and marketing approval. The basic vaccine development process and key regulatory milestones will also be covered.
Target Audience: This activity is intended for physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students
References:
- Science and the Regulation of Biological Products - From a Rich History to a Challenging Future. US Food and Drug Administration, Center for Biologics Evaluation & Research. September 2002.
- Baylor, Norman and Midthun, Karen. “Regulation and testing of vaccines”, Chapter 73 in Vaccines, Fifth Edition. Plotkin, SA, Orenstein, WA, and Offit, PA. Philadelphia: Elsevier (2008).
- Shapiro, Stuart Z., The HIV/AIDS vaccine researchers’ orientation to the process of preparing a US FDA application for an investigational new drug (IND): what it is all about and how you start by preparing for your pre-IND meeting. Vaccine 20:1261-1280, 2002.
- Federal Food Drug and Cosmetic Act (FD&C Act), June 25, 1938. Codified at 21 U.S.C. Ch. 9.
- Public Health Service Act, July 1, 1944. Codified at 42 U.S.C. Sec. 262.
- Code of Federal Regulations, Title 21, Food and Drugs, Parts 312 and 601 Washington, DC, Office of the Federal Register, National Archives & Records Administration, 2021.
Learning Objectives: After completion of this activity, the participant will be able to:
- Identify the legislative Acts leading to and authorizing FDA to regulate preventive vaccines and discuss the historical context of each.
- List basic regulatory requirements and types of data needed to support vaccine licensure and marketing approval.
- Outline the usual vaccine development process from conception to marketing and explain key regulatory milestones during the process.
Please direct your comments or questions via email to DDIWebinars@fda.hhs.gov.
For more information on live and home study CE dates, topics, and registration, please visit: www.fda.gov/DDIWebinars.
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