ALS 463
Current Issues for FDA Regulated Products

The business environment and regulatory framework pertaining to the medical products industry continue to change rapidly, as they are constantly challenged by competition, politics and new technological possibilities. The highly lucrative and competitive nature of this industry requires that professionals have a good working knowledge, background and understanding of the role regulatory strategy plays in effective product development.

ALS 463 will provide students with a broad background and understanding of several of the components that comprise a regulatory strategy for a drug product in development. The focus of the class will be on small molecule drug development, but many of the concepts will be applicable to biologic, and to a lesser extent device, regulatory strategy as well. The course will expose students to some of the most current regulatory developments in the context of strategic product development, strengthening their capacity to discuss and address contemporary issues affecting the industry. The student will become familiar with the elements that comprise a regulatory strategy and be better able to analyze, plan and navigate in the dynamic and complex medical products industry.

ALS 462, Introduction to Food and Drug Law recommended but not required for successful completion of this course. Students who have not taken ALS 462 should purchase and review the textbook required for ALS 462: Fundamentals of US Regulatory Affairs, Seventh Edition.

After completing the course, students should be able to:

1. Describe the role played by a regulatory strategist in a cross-functional medical product development team.
2. Identify the primary elements that comprise a regulatory strategy for a medical product.
3. Critically evaluate a drug development plan and identify regulatory gaps.
4. Describe the importance of, and methods for gathering, regulatory intelligence.
5. Apply the critical thinking skills necessary to make regulatory strategy-related decisions.
6. Interpret relevant regulations and guidances and apply them to medical product development.