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.
