Postapproval Research Requested by the FDA at the Time of NCE Approval,1970

Abstract

In the early 1970s, the Food and Drug Administration (FDA) began to require postapproval research at the time of approval (PAR) for some drugs, a practice that seemingly extends approval requirements beyond the provisions of the statute. This study, based primarily on a survey of the pharmaceutical industry, is the first comprehensive analysis of this phenomenon. It shows that the practice has been fairly extensive, including about one third of the new drugs approved during the period 1970–1984. PAR studies have been required for a variety of purposes, from testing in special populations to refining dosage. The practice has not been used primarily to make major therapeutic advances available earlier, but has included many drugs rated by the agency as offering only moderate or little advance over existing therapy. By defining the characteristics of the practice, this study provides a starting point for analyses that can help determine whether continuation of the practice of requiring PAR is desirable.

Keywords

Postapproval research FDA Drug development Regulation Pharmaceutical industry

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Postapproval Research Requested by the FDA at the Time of NCE Approval,1970–1984

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