Why This Course is Important
Without this course, you risk non-compliance with the FDA’s updated terminology, potentially leading to delayed reviews or approvals of your drug or biologic submissions.
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-26-2220-1