The Labyrinth of Product Development and Regulatory Approvals in Liquid Biopsy Diagnostics

Author:

Goodsaid Federico M.1

Affiliation:

1. Regulatory Pathfinders, LLC Pescadero California USA

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Reference69 articles.

1. Current and future perspectives of liquid biopsies in genomics-driven oncology

2. FDA Oversight of Laboratory-Developed Tests: Where Are We Now?

3. US Food and Drug Administration (FDA).Challenge and opportunity on the critical path to new medical products. (2004). Accessed January 30 2019.

4. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework

5. US Food and Drug Administration (FDA).Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products guidance for industry. (2019). Accessed March 31 2019.

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