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Personalized Medicine at FDA: The Scope & Significance of Progress in 2020


Personalized Medicine at FDA: The Scope & Significance of Progress in 2020 documents the U.S. Food and Drug Administration’s approval last year of 19 personalized therapies, one cell-based immunotherapy, and eight significant new diagnostic indications that will help physicians target treatments to only those patients who will benefit. Personalized medicines accounted for 39 percent of the new drugs FDA approved in 2020, topping one-third of new drug approvals for the third time in the last four years. The report underlines how FDA’s public policies are reinforcing the United States health care system’s shift toward a more effective and efficient era of personalized medicine even in the midst of a pandemic. It also demonstrates the biopharmaceutical and diagnostics industries' continued commitment to the field.

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