FDA’s Drug Center Officially Opens Pharmaceutical Quality Office

The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) Jan. 12 launched the Office of Pharmaceutical Quality (OPQ) as part of its ongoing quality initiative, according to an agency announcement.

The OPQ will streamline the FDA processes that monitor drug quality throughout a product’s life cycle, including drug application review, post-approval improvements and surveillance and inspections of global manufacturing facilities, the agency said.

The FDA said the OPQ supports CDER’s quality initiative by providing a means to:

• enhance quality drug assessment by integrating application review and facility inspection;
• establish consistent, clinically relevant quality standards and clear ...