Personalized Medicine at the FDA - 2017 progress report
U.S. Food and Drug Administration (FDA) took a leading role in 2017 in various Therapie Op Maat developments. This demonstrates the FDA's commitment to progress and acceleration of this field. More than one in every four medicines approved by the FDA is Tailor-made Therapy, a record with Therapie Op Maat 16 new treatments. The milestones achieved in 2017 are:
1. Record number of Therapy Customized approvals
2. Approval of first gene therapy
3. First approval of a tissue-independent indication for cancer therapy
4. First authorization of direct marketing to consumers of health-related genetic tests
5. First approval of a biosimilar as Tailor-made Therapy
6. First joint decision-making by FDA and Centers for Medicare and Medicaid Services for approval and reimbursement for a test with Next Generation Sequencing technology.
The complete document of Personalized Medicine Coalition can be found here.