The Office of Pharmaceutical Quality (OPQ) serves the public health through our mission of assuring the availability of quality medicines for the American public. Our organization focuses on quality, which fundamentally supports the pharmaceutical pillars of safety and efficacy. Quality is what assures that drugs safely and reproducibly deliver the intended benefit claimed in their label, over their lifecycle. It is what gives the American public confidence in the safety and efficacy of their next dose of medicine.
OPQ has published its first public annual report which describes our accomplishments in 2017. OPQ occupies a unique space at the U.S. Food and Drug Administration (FDA) by reaching across all human drug User Fee programs: new drugs and biologics, generics, and biosimilars – and also over-the-counter drugs and compounded drug products. Further, we reach across the drug product lifecycle including development, premarket, and postmarket. Many drugs are currently available to patients and consumers due to OPQ accomplishments across assessment, inspection, surveillance, policy, and research.
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