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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 12 March 1996

   Introduced

   Referred to the House Committee on Commerce.

   Source: IntroReferral

2. 12 March 1996

   Introduced

   Introduced in House

   Source: IntroReferral

3. 12 March 1996

   Introduced

   Introduced in House

   Source: IntroReferral

4. 18 March 1996

   Referred

   Referred to the Subcommittee on Health and Environment.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 12 March 1996 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 12 March 1996

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 12 March 1996

  ViewDownloadOpen at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in House

  summary · EN · 12 March 1996

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Coburn, Tom [R-OK] · R · Sponsor
• Sen. Burr, Richard [R-NC] · R · Sponsor
• Rep. Stupak, Bart [D-MI-1] · D · Sponsor
• Sen. Lincoln, Blanche L. [D-AR] · D · Sponsor
• Rep. Weldon, Dave [R-FL-15] · R · Cosponsor
• Rep. Norwood, Charles W. [R-GA-9] · R · Cosponsor
• Rep. Tauzin, W. J. (Billy) [R-LA-3] · R · Cosponsor
• Rep. Deutsch, Peter [D-FL-20] · D · Cosponsor
• Sen. Crapo, Mike [R-ID] · R · Cosponsor
• Sen. Brown, Sherrod [D-OH] · D · Cosponsor
• · hsif00 · Standing

Related records

No cross-record relationships stored yet.