HHS-Health and Human Services Department

Why This Course is Important
Without this course, you risk misunderstanding critical regulatory language changes, potentially limiting your ability to use the latest scientifically valid nonclinical methods in FDA submissions and missing key opportunities to influence the evolving rule.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Nonclinical Testing Terminology.

Key regulatory references include:

• 21 CFR Part 312 – Investigational New Drug Application
• 21 CFR Part 314 – Applications for FDA Approval to Market a New Drug
• 21 CFR Part 315 – Diagnostic Radiopharmaceuticals
• 21 CFR Part 361 – Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research
• 21 CFR Part 601 – Licensing

Course SKU
FR-26-2221-1