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FDA/industry user fee II proposal would cut review deadline to 10 months from current 12.

This article was originally published in The Tan Sheet

Executive Summary

FDA/INDUSTRY USER FEE II PROPOSAL WOULD CUT NDA REVIEW DEADLINE BY TWO MONTHS, from 12 to 10 months, for standard NDAs and biological licensing applications. Under a user fee reauthorization proposal agreed upon by FDA, the Pharmaceutical Research & Manufacturers of America and the Biotechnology Industry Organization, FDA would cut the review time for manufacturing supplements from six to four months.

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