The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more
- CMS Diagnostic Tests FDA Labeling Laboratory Developed Tests Marketing Personalized Medicine Pharmaceutical
The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment...more
- Biotechnology Clinical Trials FDA
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