S 470 · 109th Congress · Health
FACT Act
Bill Progress
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Introduced2
Committee3
Senate Vote4
House5
EnactedLatest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S1798-1803)(2005-02-28)
Plain Language Summary
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Fair Access to Clinical Trials Act of 2005 or the FACT Act - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to establish and operate a data bank of information on clinical trials, to include: (1) a clinical trials registry of health-related interventions conducted to test the safety or effectiveness of any drug, biological product, or device intended to treat serious or life-threatening diseases and conditions; and (2) a clinical trials results database of health-related interventions to test the safety or effectiveness of any drug, biological product, or device. Requires the Commissioner of Food and Drugs to make available to the public: (1) the full reviews conducted by the Food and Drug Administration (FDA) of new or supplemental new drug applications; and (2) copies of written consultations on a drug's safety conducted by the Office of Drug Safety. Requires the Secretary to assess civil monetary penalties for failure to comply with the reporting requirements of this Act. Allows the Secretary to correct any information included in the registry or database that is …
Summarized by Claude AI · Non-partisan · For informational purposes only
Cosponsors (7)
4 Democrats3 Republicans