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FDA NDA submission summary data draft guidance expected out before year-end.

This article was originally published in The Tan Sheet

Executive Summary

FDA DRAFT GUIDANCE ON SUMMARY DATA IN NDA SUBMISSIONS, including Rx-to-OTC switches, is expected to be published by the agency before the end of the year. Under the provisions of Sen. James Jeffords' (R-Vt.) proposed Senate FDA reform bill (S 830), FDA has 12 months following passage of the legislation to provide industry with a guidance "that describes when abbreviated study reports may be submitted, in lieu of full reports," with an NDA, such as for a switch application, according to bill language as reported out of Jeffords' Senate Labor & Human Resources Committee.

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