GAO Criticizes FDA/CTP’s Lack of Performance Measures for Substantial Equivalence Product Submissions

Editor’s Note:  The GAO report “NEW TOBACCO PRODUCTS: FDA Needs to Set Time Frames for Its Review Process” is attached here.  In the report, GAO recommended “that FDA establish performance measures that include time frames for making decisions on new tobacco product submissions and that the agency monitor performance relative to those time frames.”  In HHS’ response to the report, ther Department committed to a series of measures to implement GAO’s recommendations.  CRE, a regulatory watchdog, will track and report on FDA/CTP’s response to GAO.

Below is an excerpt from the Department of Health and Human Services comments on the report.

“Within 6 months of the publication of this report, FDA will identify performance measures that include timeframes for regular SE and Exemption from SE review processes.  FDA will implement these performance measures for regular SE reports received by the agency within 6 months after identification.  In addition, FDA will monitor its progress to determine if subsequent SE reviews meet the identified timelines.”

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