# Investigational New Drugs: Export Requirements for Unapproved New Drug Products
> **Food and Drug Administration** · Final rule. · Published 2005-11-23 · Effective 2005-12-23 · 70 FR 70720
## Document
- **Document number:** 05-23120
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 70 FR 70720
- **CFR reference:** 21 CFR 312
- **Publication date:** 2005-11-23
- **Effective date:** 2005-12-23
- **HHS docket:** Docket No. 2000N-1663
## Abstract

The Food and Drug Administration (FDA) is amending its regulations on the exportation of investigational new drugs, including biological products. The final rule describes four different mechanisms for exporting an investigational new drug product. These provisions implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996 and also simplify the existing requirements for exports of investigational new drugs.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2005/11/23/05-23120/investigational-new-drugs-export-requirements-for-unapproved-new-drug-products)
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