New War on Cancer Act

Summary

New War on Cancer Act - Allows the sponsor of a drug intended for use for cancer to request the Secretary of Health and Human Services to: (1) provide written recommendations for investigations which must be conducted before approval of a drug or before licensure of a biological product for use for cancer; and (2) designate such drug as a cancer drug before the submission of a request for approval or licensing. Requires the Secretary to designate such drug as a cancer drug if the drug is being or will be investigated for use for cancer. Prohibits the Secretary from approving another application or issuing another license for a designated cancer drug for a person who is not the holder of the approved application or license until the expiration of seven years, with certain exceptions. Requires the Secretary to encourage the sponsor of a designated cancer drug approved for investigational use to design protocols for the drug that include persons with the cancer involved who cannot be satisfactorily treated by alternative drugs. Extends the time during which an application for approval of drug with the same active ingredient as an approved cancer drug may not be approved. Excludes approved cancer drugs from time limits imposed on the maximum length of a patent.

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Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 8 October 2004

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• Introduced in House (PDF)

  Introduced in House · EN · 8 October 2004

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• Introduced in House

  summary · EN · 8 October 2004

  Open at official source

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