The course, a Thomson Reuters Cortellis Regulatory Online Learning module, describes the foundation and organization of US government institutions and regulatory authorities, federal rulemaking processes, and the legal basis for and evolution of US food and drug legislation. It explores in detail the roles and responsibilities of the Department of Health and Human Services (HHS) and Food and Drug Administration (FDA). The course concludes with an overview of the FDA review and approval process for new drug applications (NDAs) and biological license applications (BLAs).
- US government institutions and regulatory authorities
- US food and drug legislation
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields
Participants who complete this course should be able to:
- Describe the structure and functions of the US government
- Outline the federal rulemaking process
- Identify the milestones of US food and drug laws and regulations
- Discuss the role and organisation of the Department of Health and Human Services
- Explore the functions and structure of the Food and Drug Administration
- Introduce the new drug application (NDA) and biologics license application (BLA) review process
The course takes an average of 1.5 hours to complete.