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Personalized Medicine at FDA: A Progress & Outlook Report


Personalized Medicine at FDA: A Progress & Outlook Report documents the record number of new personalized medicines the U.S. Food and Drug Administration (FDA) approved in 2018, the fifth consecutive year that personalized medicines accounted for more than 20 percent of all new drug approvals.

The annual analysis shows that personalized medicines set a new record in 2018 by topping 40 percent of all new drug approvals, and underlines the importance of supportive public policies that will facilitate continued progress.

The report lists a total of five regulatory precedents FDA set in 2018, as follows:

  1. Record number of 25 personalized medicine approvals
  2. Second approval of a cancer drug indication based on biomarker, not tumor type
  3. First approval of a therapy from a new class of personalized drugs called small interfering ribonucleic acid (siRNA) treatments
  4. Marketing authorization of first pharmacogenetic and cancer risk-related genetic tests sold directly to consumers
  5. Recognition of first public database to support regulatory oversight of variant/disease claims: ClinGen database

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