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FDA “Refuse-To-File” Decisions Encouraged For Incomplete, Poor NDAs – IG

This article was originally published in The Tan Sheet

Executive Summary

FDA should consider issuing "refuse-to-file" decisions more often for incomplete or inadequate NDAs, the HHS Inspector General recommended in a report released March 25

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Roughly half of the 74-day "issue" letters sent by FDA to NDA applicants in the first six months of the agency's 2003 fiscal year have noted application flaws, Office of New Drugs Director John Jenkins, MD, said at Temple University's annual industry/FDA conference in Philadelphia April 15

FDA Has “Issues” With NDAs; Half Of 74-Day Letters Note Application Flaws

Roughly half of the 74-day "issue" letters sent by FDA to NDA applicants in the first six months of the agency's 2003 fiscal year have noted application flaws, Office of New Drugs Director John Jenkins, MD, said at Temple University's annual industry/FDA conference in Philadelphia April 15

FDA Has “Issues” With NDAs; Half Of 74-Day Letters Note Application Flaws

Roughly half of the 74-day "issue" letters sent by FDA to NDA applicants in the first six months of the agency's 2003 fiscal year have noted application flaws, Office of New Drugs Director John Jenkins, MD, said at Temple University's annual industry/FDA conference in Philadelphia April 15

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