ANDA Approvals May Be Hindered By New Elemental Impurities Requirements
US FDA's generic approval total in January was dramatically lower than recent monthly tallies, raising questions about impact of requirements that took effect at beginning of the year.
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In the first quarter of FY 2018, the agency issued over 800 CRs for generic drug applications, more than half the total it issued in all of FY 2017.
Manufacturing Regulatory Updates In Brief: Elemental Impurities, Class 3 Biowaivers, FDA Salt Policy
Manufacturing US regulatory updates for December 2017: Elemental impurities requirements begin Jan. 1, final guidance confirms BCS Class 3 biowaivers option, and FDA MAPP implements USP salt policy.
Performance numbers are likely to fluctuate over the course of the program, but the rate of first-cycle approvals during the first month of the new user fee program is more than double the rate during the last year of the old iteration.