martes, 14 de mayo de 2019

FDA/CDER Report on the State of Pharmaceutical Quality


FDA Center for Drug Evaluation and Research (CDER)
Office of Pharmaceutical Quality
Report on the State of Pharmaceutical Quality

The FDA’s Office of Pharmaceutical Quality (OPQ) has released a report on the ‘State of Pharmaceutical Quality’ - a yearly snapshot of the pharmaceutical manufacturing industry’s ability to deliver quality products to the U.S. market. The report is an objective assessment using quality indicators based on available FDA drug product-specific and manufacturing site-specific data.

The FDA uses the State of Pharmaceutical Quality to, among other things, inform regulatory decision-making and surveillance activities. The FDA has now provided this report publicly so our external stakeholders can better understand the quality of the U.S. drug supply, pharmaceutical manufacturers can further join us in a commitment to quality, and we can better inform U.S. patients and consumers. It is our public health mission to assure patients and consumers have access to safe, effective, quality medicines.

To read the report, please visit: Report on the State of Pharmaceutical Quality.

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