Abbreviated Reports May Be Submitted for Studies Not Central To Efficacy
This article was originally published in The Tan Sheet
Executive Summary
Abbreviated data reports may be submitted for efficacy, safety and pharmacology studies that are not central to efficacy claims for a specific indication, FDA indicates in its guidance for industry on "Submission of Abbreviated Reports and Synopses in Support of Marketing Applications."
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FDA guidance
"Submission of Abbreviated Reports and Synopses in Support of Marketing Applications" guidance, expected to appear in the Sept. 13 Federal Register, describes when studies that are part of an NDA may be submitted to FDA in abbreviated form and describes the format abbreviated submissions should follow. The agency estimates the resulting reduction in burden for industry will be 300 hours. A draft of the guidance appeared in the Sept. 21 Federal Register (1"The Tan Sheet" Sept. 28, 1998, p. 24). Comments may be submitted at any time
FDA guidance
"Submission of Abbreviated Reports and Synopses in Support of Marketing Applications" guidance, expected to appear in the Sept. 13 Federal Register, describes when studies that are part of an NDA may be submitted to FDA in abbreviated form and describes the format abbreviated submissions should follow. The agency estimates the resulting reduction in burden for industry will be 300 hours. A draft of the guidance appeared in the Sept. 21 Federal Register (1"The Tan Sheet" Sept. 28, 1998, p. 24). Comments may be submitted at any time
FDA guidance
"Submission of Abbreviated Reports and Synopses in Support of Marketing Applications" guidance, expected to appear in the Sept. 13 Federal Register, describes when studies that are part of an NDA may be submitted to FDA in abbreviated form and describes the format abbreviated submissions should follow. The agency estimates the resulting reduction in burden for industry will be 300 hours. A draft of the guidance appeared in the Sept. 21 Federal Register (1"The Tan Sheet" Sept. 28, 1998, p. 24). Comments may be submitted at any time