FDA launches Office of Pharmaceutical Quality

The US Food and Drug Administration has launched an Office of Pharmaceutical Quality in a bid to clamp down on manufacturing problems experienced by some generic drug producers.

The aim is to make manufacturing more systematic. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said the OPQ aims to create parity between brand-name and generic drugs by removing the manufacturing issues experienced by some generic drug producers.

Dr Woodcock added that the OPQ will provide the FDA with more quantitative information. Drugs being assessed at the moment will stay with their existing review team at the FDA, while new applications will be filed with the OPQ immediately.