References

Fox AW (2002) Erosion of the scope of the United States Orphan Drug Act. Int J Pharmaceut Med (in press) [a response from Dr Haffner accompanies this article].

Haffner M (2002) Orphan drug product regulation—United States. Int J Clin Pharmacol Ther (in press).

Spilker B (1991) Guide to Clinical Trials. Raven: New York.

Spilker B (1994) Multinational Pharmaceutical Companies: Principles and Practices, 2nd edn. Raven: New York.

Spilker B (1996a) Orphan Drug Challenges for Pharmaceutical Companies. Drug News Perspect 9(7): 399.

Spilker B (1996b) Orphan Drug Act of1983. Drug News Perspect 9(8): 460.

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