Course: Proposed Rule on Profits and Related Basis Adjustments based on this document from the Federal Register: https://www.govinfo.gov/content/pkg/FR-2024-12-02/pdf/2024-27227.pdf This document contains proposed regulations regarding previously taxed earnings and...
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Nonprescription Drug Products: Navigating New FDA Conditions
This course provides an in-depth look at the FDA’s final rule for nonprescription drugs that have an Additional Condition for Nonprescription Use (ACNU). Participants will learn about the critical application, labeling, and postmarketing requirements. The course also explains the reasons behind the delayed implementation date and how this impacts stakeholders.
In this course you will learn the following:
* Understand the purpose and scope of the final rule on nonprescription drug products with an ACNU.
* Identify the key requirements for applications, labeling, and postmarketing reporting.
* Recognize the implications of the delayed effective date and the reasons for the delay.
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Additional information
| Federal Register Title | Nonprescription Drug Product With an Additional Condition for Nonprescription Use. Document Number: 2025-04978 |
|---|---|
| Course SKU | FR-25-1280-1 |
| Why This Course Is Important | By not taking this course, you risk non-compliance with the FDA's critical regulatory standards, potentially leading to application rejections and legal issues. |