HR 1995 · 104th Congress · Health
Life Extending and Life Saving Drug Act
Bill Progress
✓
Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Sponsor introductory remarks on measure. (CR H2464-2465)(1996-03-19)
Plain Language Summary
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Life Extending and Life Saving Drug Act - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to declare that the mission of the Food and Drug Administration (FDA), with regard to drugs, biological products, and devices, is to promote and protect the health of the American people. (Sec. 3) Declares that investigations to show a new drug or biological product is safe and effective shall be required to be performed using products manufactured at a full-scale commercial facility only if necessary. Mandates actions to harmonize FDCA requirements for preclinical and clinical investigations with similar foreign laws through the International Conference on Harmonization. (Sec. 4) Amends the Public Health Service Act to revise requirements regarding the regulation of biological products. Regulates tissue, blood, and blood components and derivatives separately. Mandates approval of product license applications on a demonstration that there is reasonable assurance that the product is safe and effective. Specifies license requirements. Mandates standards for tissue, blood, and blood components or derivatives. (Sec. 5) Amends the FDCA to mandate regulations regarding good manufacturing prac…
Summarized by Claude AI · Non-partisan · For informational purposes only
Cosponsors (15)
1 Democrat14 Republicans