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H.R. 3065

Radiopharmaceutical Review Improvement Act of 1996

Radiopharmaceutical Review Improvement Act of 1996 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to require that the safety and effectiveness of a radiopharmaceutical be determined: (1) weighing the probable health benefit against any probable risk of injury or illness; and (2) taking into account the absence or presence of pharmacological and toxicological activity of the radiopharmaceutical and the estimated absorbed dose. Allows the indications for which a radiopharmaceutical intended for diagnostic purposes is approved to refer to processes, processes common to or present in one or more disease states, or a diagnostic procedure used in the diagnosis of one or more diseases. Requires that, if a radiopharmaceutical is the primary mode of action in a combination of drugs, the persons charged with premarket review of radiopharmaceutical products have primary regulatory jurisdiction.

Referred to the Subcommittee on Health and Environment.

Rep. Coburn, Tom [R-OK-2](R-OK)Sponsor
9 cosponsors4 D5 R
9cosponsors1committees4actions11subjects
  1. CommitteeH11000

    Referred to the Subcommittee on Health and Environment.

    Health and Environment Subcommittee
  2. IntroReferralH11100

    Referred to the House Committee on Commerce.

    Energy and Commerce Committee
  3. IntroReferralIntro-H

    Introduced in House

  4. IntroReferral1000

    Introduced in House

Radiopharmaceutical Review Improvement Act of 1996 — Informed