|  FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | OPQ Issues Annual Report for 2020 The Office of Pharmaceutical Quality (OPQ) within FDA's Center for Drug Evaluation and Research published their 2020 annual report describing accomplishments throughout the year including OPQ's response activities related to the COVID-19 pandemic. OPQ staff worked tirelessly during this challenging year to ensure that the pandemic minimally impacted the availability of high-quality medicines in the United States. OPQ's collaborative and innovative nature is highlighted through efforts across drug assessment, inspection, surveillance, policy, and research. OPQ's accomplishments continue to support patient and consumer access to needed medicines. OPQ has a unique role at the FDA working on activities that impact all human drug user fee programs: new drugs, generics, biologics (including biosimilars), and over-the-counter drugs. FDA has the same expectations for quality for all classes of drugs whether made in the U.S. or abroad, and OPQ works to assure that quality medicines are available to the American public. 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 meet 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, especially in the face of a global pandemic. Please read OPQ's Annual Report and join us in a commitment to quality. | | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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