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 Proposed Rule: Nonclinical Testing Terminology Updates for Drug and Biologic Regulation
$129.99
Stay ahead in regulatory science with this comprehensive course on the FDA’s proposed updates to nonclinical testing terminology. Learn how recent amendments will replace ‘animal’ with ‘nonclinical’ in FDA regulations, expanding the recognized methodologies for drug and biologic safety assessments. The training covers the regulatory and statutory context, new definitions, and the shift towards innovative approaches like in vitro and in silico testing. Equip yourself with practical knowledge to adapt your submissions and participate effectively in the ongoing rulemaking process.
In this course you will learn the following:
* Explain the purpose and goals of the proposed rule.
* Identify the major terminology changes and their implications.
* Understand the regulatory and policy context for nonclinical testing.
* Recognize the opportunities for public comment and the rulemaking process.
* Describe the potential impacts and benefits of the proposed changes.
* Acknowledge that the rule is not final and may evolve based on feedback.
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 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