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

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.