Investigational New Drugs: Export Requirements for Unapproved New Drug Products
other · Food and Drug Administration · Rule · Published 2005-11-23 · Effective 2005-12-23 · 70 FR 70720
Document
Document number
05-23120
Federal Register citation
70 FR 70720
CFR reference
21 CFR 312
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
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.