significant extent in the United States, and thus would not be likely candidates for market approval in the United States. Export approval permits for track 2 products are not limited to the 21 specified industrialized countries. Normally, the FDA anticipates that approval under track 2 would ordinarily be based on data from two well-controlled clinical trials, but that the trials would not necessarily have to meet the full detail and documentation requirements necessary for approval of a U.S. marketing application. However, there must be evidence that the product is safe and effective for the intended use in the country to which it is to be exported.

Finally, the act permits the FDA to approve the export of partially processed human biological products that are intended for further manufacture in one or more of the same set of 21 specified industrialized track 1 countries. These track 3 products must be approved, or be in the process of being approved, in the country of destination (U.S. Food and Drug Administration, 1990).


Hopps HE, Meyer BC, Parkman PD. 1988. Regulation and testing of vaccines. Vaccines, Plotkin SA and Mortimer EA. eds. Philadelphia: W.B. Saunders Company.

U.S. Food and Drug Administration. 1990. A Review of FDA's Implementation of the Drug Export Amendments of 1986. Rockville, Maryland.

Weber JCW. 1991. Regulatory Aspects of Vaccine Development. Vaccines for Fertility Regulation, Ada GL and Griffin PD, eds. Cambridge: Cambridge University Press.

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