Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Regulation Crypto Assets. Document Number: 2026-17183
Buy this Course
FR-26-2164-1
FDA Nonclinical Testing Terminology Rule: Key Regulatory Updates for Drug and Biologic Submissions
$49.99
This course delivers a focused breakdown of the FDA’s direct final rule that replaces outdated terminology in human drug and biological product regulations. Learn exactly how to update your regulatory submissions and internal documentation by adopting ‘nonclinical’ instead of ‘animal’, ‘preclinical’, or ‘in vitro’ in all relevant contexts. Master the new definitions as they apply to IND, NDA, BLA, and postmarketing materials. Ensure your organization is prepared for the compliance deadline and avoids costly regulatory delays.
In this course you will learn the following:
* Identify the key terminology changes and their regulatory context.
* Understand the expanded definition of “nonclinical test” and “nonclinical study.”
* Apply the new terminology in regulatory submissions and communications.
* Recognize the impact of these changes on compliance and reporting.
* Understand the consequences of non-compliance with the updated regulations.
NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year. At the end of the one year term, the course will be set to “inactive”.
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