FDA Final Rule: Amended Export Requirements for Unapproved New Drug Products

November 23, 2005

FDA Final Rule: Amended Export Requirements for Unapproved New Drug Products

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.

Click here to read the Federal Register notice