Radiopharmaceutical Review Improvement Act of 1996
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in house (Mar 12, 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.
What just happenedMar 18, 1996
Referred to the Subcommittee on Health and Environment.
Who’s behind it
- Introduced in HouseMar 12, 1996
- Mar 18, 1996CommitteeH11000
Referred to the Subcommittee on Health and Environment.
Health and Environment Subcommittee - Mar 12, 1996IntroReferralH11100
Referred to the House Committee on Commerce.
Energy and Commerce Committee - Mar 12, 1996IntroReferralIntro-H
Introduced in House
- Mar 12, 1996IntroReferral1000
Introduced in House