FDA accountability for review times sought in Senate GOP concept paper.
This article was originally published in The Tan Sheet
Executive Summary
FDA ACCOUNTABILITY FOR REVIEW DEADLINES IS SOUGHT in Senate Labor & Human Resources Committee Chair Nancy Kassebaum's (R-Kan.) FDA reform concept paper. If the agency "fails to meet statutory deadlines for product review," the paper states, the appropriate FDA office director would be required "within seven days of the missed deadline" to inform the product sponsor in writing: "(1) of the reasons why additional time is necessary; (2) each remaining issue relating to the application; and (3) the projected date for completion."