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    31 May 2018

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  • RIVM analysis: Personalised medicine in medical practice

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Personalized Medicine at the FDA – 2017 progress report

Thursday 31 May 2018

 The U.S. Food and Drug Administration (FDA) spearheaded several significant developments in personalized medicine in 2017 that demonstrate the agency’s commitment to advancing and accelerating the field. More than one of every four drugs the agency approved over the past four years is a personalized medicine, and FDA approved a record number of 16 new personalized medicines in 2017. The achieved milestones are:

1. Record number of personalized medicine approvals

2. Approval of first three gene therapies

3. First approval of tissue agnostic indication for cancer therapy

4. First authorization for marketing of health-related genetic tests directly to consumers

5. First approval of personalized medicine biosimilar

6. First FDA/CMS joint approval and coverage decision for test using next-generation sequencing technology

Find the full report from the Personalized Medicine Coalition here