OPQ Issues Annual Report for 2021 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. The Office of Pharmaceutical Quality (OPQ) in FDA's Center for Drug Evaluation and Research is proud to share our latest annual report describing our accomplishments in assessment, inspection, surveillance, policy, and research. These accomplishments have enabled patient and consumer access to critical medicines throughout the COVID-19 pandemic. OPQ's annual report offers a brief glimpse into the work OPQ's talented staff does every day to impact all human drug user fee programs: new drugs, generics, biologics (including biosimilars), and over-the-counter drugs. OPQ maintains a surveillance site and product catalog of over 6,000 global drug manufacturers and over 275,000 products. In 2021, OPQ performed greater than 90% of actions before the user fee goal date and supported the approval of over 850 drugs, while passing the milestone of approving over 1,000 submissions to assist in treating patients with COVID-19 since the start of the pandemic. Some of these approvals required international inspections that made OPQ staff endure long quarantines keeping them isolated from their families and friends. Many of OPQ's laboratory scientists have continued to work on site, following safety precautions, to perform mission-critical work throughout the pandemic. OPQ's policy teams have continued to work with global regulatory counterparts on international matters, in the absence of travel, at all hours of the day and night. OPQ staff do this because they know that medicine is the foundation of a healthy country. All Americans deserve safe, effective, quality medicine and the assurance that their next dose will be available when they need it. | 
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