Module 11
The US Regulatory Environment
Aim
The USA is the largest single country market for pharmaceutical products in the world. As such, the regulatory requirements of the US Food and Drug Administration have a major influence on the design of pharmaceutical development programmes aimed at achieving successful registration in both the USA and globally. This influence impacts to some extent on all Regulatory Affairs Professionals, whether directly involved with the USA or not. The purpose of this Module is to provide students with an understanding of the regulatory environment in the USA in order to place these global influences in perspective.
Learning outcomes
- Students will examine the legal basis of pharmaceutical regulations in the USA and how the FDA operates within the legal framework.
- Students will differentiate the format and content of IND, NDA, BLA, ANDA and SNDA submissions, and examine the practical issues associated with these applications.
- Students will analyse FDA approaches to specific product types such as OTC products and orphan drugs.
- Students will assess the impact of US Regulatory Affairs on the global development and regulatory strategy for pharmaceuticals.
Outline of Module topics
- History of drug regulation in the USA
- The legal basis of Regulatory Affairs in the USA
- Recent legislation (PDUFA and FDAAA)
- The IND
- The NDA and BLA
- The ANDA
- The SNDA
- OTC products
- Orphan drugs
- Fast track approvals
- Adverse event reporting
- Labelling, advertising and advertising controls
- Communicating with the FDA.