Radiopharmaceutical Review Improvement Act of 1996

Summary

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.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 12 March 1996

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• Introduced in House (PDF)

  Introduced in House · EN · 12 March 1996

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• Introduced in House

  summary · EN · 12 March 1996

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