Drug Regulation Improvement Act of 1979

Summary

Drug Regulation Improvement Act of 1979 -- Amends the Federal Food, Drug, and Cosmetic Act to allow submission of a comprehensive summary of investigations in lieu of full reports in the application for approval of a new drug. Specifies the general contents of such a summary. Authorizes an unsuccessful applicant to request a review of a disapproved application by an advisory committee composed of representatives of consumer and health care provider interests and qualified scientific experts. Directs the Secretary of Health, Education, and Welfare to promulgate regulations requiring any person who intends to conduct a drug research investigation to obtain a drug research registration before dispensing, or allowing to be dispensed, a drug as part of the investigation. Directs the Secretary to determine categories of investigations, and to authorize review of applications and issuance of registrations by institutions primarily engaged in health care research or delivery (excluding an establishment engaged in the manufacture or distribution of a drug for commercial purposes).

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Timeline

1. 15 May 1979

   Introduced

   Introduced in Senate

   Source: IntroReferral

2. 15 May 1979

   Introduced

   Referred to Senate Committee on Labor and Human Resources.

   Source: IntroReferral

Votes

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Versions

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Documents

1 official file

• Introduced in Senate

  summary · EN · 15 May 1979

  Open at official source

Sponsors

• Sen. Schweiker, Richard S. [R-PA] · R · Sponsor
• · sshr00 · Standing

Related records

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