The US Regulatory Environment

The course provides an in-depth overview of the US FDA organization, history, legal standing and roles and responsibilities in the new drug and biologics approval, registration, and marketing process.  The structure of the FDA and its relationship to the US government, international pharmaceutical companies, and the EMA is defined. 

Requirements and recommendations for interaction with the FDA are presented for each step in the drug and biologics development process, including meeting requests, briefing materials and documentation, and dispute resolution.  Technical and regulatory requirements and expectations  for nonclinical, clinical, and chemistry and manufacturing portions of IND, NDA, BLA, and ANDA submissions are described, and the impact of key FDA Guidance documents explained. Specific similarities and differences between the FDA and EMA are presented, especially major differences in technical requirements and regulatory authority, so that students understand the US FDA in the context of world-wide regulatory submissions and approvals.  Post approval areas regulated by the FDA including direct-to consumer advertising, life cycle management and risk management compliance, are discussed. 

Interactive web-based demonstrations are used to introduce students to the FDA website, navigate to critical areas of the website and retrieve information, and understand key concepts in drug marketing in the US.  A group exercise of a mock interaction with the FDA reinforces the concepts discussed in the lectures. After completing the course, the student will have an overview of the FDA structure, specific recommendations for communicating with the FDA during all phases of drug and biologics development, and how regulatory affairs professionals can interact and lead drug development teams in obtaining approval for new drugs and biologics in the US.