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FDA supplemental applications working group has May 20 deadline to issue guidance.

This article was originally published in The Tan Sheet

Executive Summary

FDA SUPPLEMENTAL APPLICATIONS WORKING GROUP MAY 20 DEADLINE is set for the issuance of a guidance to industry to "clarify the requirements for, and facilitate the submission of data to support, the approval of supplemental applications." The May 20 deadline is mandated by the FDA Modernization Act (FDAMA) as is the formation of other working groups to implement all provisions of the law ("The Tan Sheet" Feb. 9, In Brief). FDAMA also set a 180-day deadline for FDA to publish standards for prompt review of supplements in the Federal Register.
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