RA102 Introduction to Regulatory Pathways for Drugs, Biologics, Devices, Combination Products and Dietary Supplements

Regulatory pathways for drugs, biologics, devices, combination products, and dietary supplements refer to the different processes that these products must go through to be approved for use by regulatory agencies such as the United States Food and Drug Administration (FDA). They involve a variety of different processes and requirements, depending on the type of product and the level of risk associated with its use. These regulatory pathways are in place to ensure that products are safe, effective, and of high quality before they are made available to the public.

This course is designed to introduce the U.S. regulatory framework, including regulations and regulatory agencies governing medical products and the food market in the US. The course, also, discusses the history of popular food and drug laws and regulations while presenting an overview of the processes related to developing and filing a drug, biologic, device, combination product, or dietary supplement marketing application.

Learning Points:

• History of Food, Drug and Cosmetics Laws
• Introduction to U.S. Regulatory System
• Regulatory Bodies Overview
• Drug Product Overview and Special Regulatory Streams
• CTD Format and Content
• Submissions and Other Regulatory Requirements for Drugs, Biologics, Medical Devices, Dietary Supplements, Homeopathic Drugs, Medical Foods and Combination Products
• Regulatory Strategies