Investigational New Drugs: Export Requirements for Unapproved New Drug Products

Streszczenie

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