HR 5306 · 108th Congress · Health
New War on Cancer Act
Bill Progress
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Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.(2004-11-05)
Plain Language Summary
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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 appr…
Summarized by Claude AI · Non-partisan · For informational purposes only