Personalized Medicine at FDA: 2017 Progress Report

DownloadPersonalized Medicine at FDA: 2017 Progress Report documents the record number of new personalized medicines the U.S. Food and Drug Administration (FDA) approved in 2017, the fourth consecutive year that personalized medicines accounted for more than 20 percent of all new drug approvals.

The annual analysis shows that FDA approved a record number of 19 personalized medicines — 16 new molecular entities and three gene therapies — in 2017. The report lists a total of six regulatory precedents FDA set last year, as follows:

  1. Record number of 16 personalized medicines approved as new molecular entities
  2. Approval of first three gene therapies
  3. First approval of a tissue agnostic indication for cancer therapy
  4. First authorization for marketing of health-related genetic tests directly to consumers
  5. First approval of a personalized medicine biosimilar
  6. First FDA/CMS joint approval and coverage decision for a next-generation sequencing test

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