FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

OGD Aims to Finish Up Work on Scientific Priorities From Prior Years

Nov. 3, 2016

The FDA’s Office of Generic Drugs is going to focus on meeting its scientific priorities from previous years, instead of setting out to accomplish new projects for this fiscal year – the final year of the five-year authorization for GDUFA.

The OGD will specifically concentrate on the following areas: postmarket evaluation of generics; equivalence standards for complex drug products and locally acting products; therapeutic equivalence evaluation; and computational tools.

The office will pick up where it left off and continue its research on evaluating modified release formulations, identifying the role replica design studies can play in determining bioequivalence and piloting surveillance methods for generics using the Sentinel program.

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