CDER's Office of Pharmaceutical Quality (OPQ) Issues Annual Report for 2018

The Office of Pharmaceutical Quality (OPQ) has published a public annual report describing our accomplishments in 2018, including contributing to record numbers of application approvals and introducing new programs in quality metrics and site engagement. OPQ is responsible for assuring the quality of most human drugs marketed in this country. A quality product of any kind consistently meets the expectations of the user. Drugs are no different. Patients and consumers expect safe and effective drugs with every dose they take. All drugs marketed in the U.S. must be manufactured to meet established quality standards that ensure every dose is safe and effective – and free of contamination and defects. Quality is what gives patients and consumers confidence in their next dose of medicine.  OPQ has a unique role at the U.S. Food and Drug Administration, with activities that impact all human drug user fee programs: new drugs, generics, and biologics – including biosimilars. Further, we oversee quality across the drug product lifecycle including development, premarket, and postmarket. OPQ accomplishments across assessment, inspection, surveillance, policy, and research have helped support availability of drugs for patients and consumers.  We look forward to enhancing our contribution to pharmaceutical quality in 2019. As one of our stakeholders, we invite you to join us in a commitment to pharmaceutical quality. It is our shared goal to assure the American public has access to safe, effective, quality medicines. Additional information is available at: 2018 Office of Pharmaceutical Quality Annual Report Office of Pharmaceutical webpage