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NDA reviews could not be delayed due to integrity issues under PhRMA FDA reform bill.

This article was originally published in The Tan Sheet

Executive Summary

NDA REVIEWS COULD NOT BE DELAYED DUE TO DATA INTEGRITY ISSUES UNDER PhRMA's PROPOSAL on FDA reform. According to reform legislation drafted by the Pharmaceutical Research & Manufacturers of America, "no action by" FDA on "any matter relating to a new drug or a biologic may at any time or under any circumstance be delayed because...of issues relating to the integrity of data, except on the basis of evidence presented to the applicant, followed by an informal hearing, that data in that particular application are false." FDA's current practice is to suspend review of all applications from a sponsor when questions are raised about data integrity in any application.
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