CDER Issues 2021 New Drug Approvals Report
FDA’s Center for Drug Evaluation and Research has issued its report, Advancing Health Through Innovation: New Drug Therapy Approvals. This annual report illustrates our role in bringing innovative drug therapies that are safe and effective to patients in need. As in the past, the new drugs approved last year span many areas of medicine and disease areas.
Our report showcases the innovative drugs we evaluated for safety and efficacy, as well as important regulatory tools we used to expedite the review and approval of these applications. We approved nearly all of these drugs by or before their goal dates as defined by congressionally authorized agreements with industry (referred to as user fee programs). Most drugs were also approved in the U.S. before any other country.
This is our 11th consecutive year of reporting CDER’s notable drug approvals. It is also our fifth consecutive year of publishing an expanded version of the report with an overview of non-novel notable approvals — for instance, approvals in which a previously approved drug will be used to treat a different disease or a new patient population, such as children.
This report helps promote a greater understanding of the CDER mission to improve treatment options for patients.
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