Course Description
Introduction to the drugs, biologics, and devices regulated by the Food and Drug Administration (FDA) and the pharmaceutical, biotechnology, and medical device industries. Organization of the FDA, basic understanding of regulatory framework in the U.S., including regulations and regulatory process, overview of product development, and new product applications process and post- marketing/commercialization compliance expectations.
Athena Title
Drugs Biologics Devices FDA
Non-Traditional Format
This course will be taught 95% or more online.
Prerequisite
Permission of department
Grading System
A - F (Traditional)
Course Objectives
- Understand the organization of the FDA and identify the different Centers within the FDA and their responsibilities. - Outline the product development process for products regulated by the FDA, including the clinical trial process. - Recognize the regulatory standards used by the pharmaceutical, biotechnology, and medical device industry to develop their products. - Differentiate the process for new product applications and generic applications. - Describe the pre-approval and approval regulatory process for new and existing products, including the planning and implementation of clinical studies. - Define at a high level the post-marketing surveillance and compliance requirements for products regulated by FDA. - Locate information and references within the FDA website, including regulations, guidelines, and policies. - Distinguish between the subjective and interpretive aspects of the regulations and develop an appreciation of the complex interaction between regulatory and development processes that facilitates the marketing and maintenance of the products regulated by FDA.
Topical Outline
- Introduction to regulatory affairs, organization of the FDA - Process for product development and commercialization of pharmaceuticals, biologics, medical devices, animal health, and combination products - Regulatory process for clinical trials, product applications and approvals, and post-marketing surveillance and compliance commitments.
Syllabus