Orphan Drug Amendments of 1988

Summary

Orphan Drug Amendments of 1987 - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services to approve an application for a license during the usual seven year moratorium on second applications for approving, certifying, or licensing drugs for rare diseases or conditions (orphan drugs) if the second application is not made by a holder of an approved application. Requires requests for designation as an orphan drug to be made before the submission of an application. Requires manufacturers of such drugs, if investigations before an application has been approved are being conducted, to notify the Secretary if the manufacturer decides to discontinue pursuit of approval of an application. Makes financial assistance available for the development of medical devices and medical foods. Authorizes appropriations for FY 1988 through 1990. Directs the Secretary to study and report to the appropriate congressional committees on whether other aspects of the orphan drug law should be expanded to encourage the development of medical devices and foods. Extends until February 1, 1989, the date by which the National Commission on Orphan Diseases shall report to the Congress on the National Institutes of Health's work in the area of rare diseases and conditions.

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Documents

4 official files

• Public Law (PDF)

  Public Law · EN · 19 April 1988

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• Passed House amended

  summary · EN · 22 March 1988

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• Reported to House with amendment(s)

  summary · EN · 10 December 1987

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• Introduced in House

  summary · EN · 9 October 1987

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