Generic Drug Super Office Takes Shape

The Office of Generic Drugs (OGD) is readying for its shift to a larger and more complex organization on par with offices for new drugs, drug safety, and compliance in FDA’s Center for Drug Evaluation and Research (CDER). Under the new generic drug user fee program (GDUFA), OGD is expanding its staff, working through a massive backlog of abbreviated new drug applications (ANDAs) and prior approval supplements, and assessing the completeness of drug master files in addition to evaluating more ANDAs and supplements.

The expanded OGD will have a strong clinical presence to assess bioequivalence and other tests, explained OGD acting director Kathleen Uhl at the Generic Pharmaceutical Association’s technical conference in October. An office of research will carry out studies to support development of more complex generic dosage forms, while an office of generic drug policy will develop guidance and internal procedures, Uhl noted. Chemists and microbiologists will join the new Office of Pharmaceutical Quality (OPQ), when it is established next year to unify the oversight of manufacturing and quality performance for all drugs, including biotech therapies.