Tag Archives: U.S. Food and Drug Administration (FDA)

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

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 American Clinical Laboratory Association, the College of American Pathologists, and the Association for Molecular Pathology, have weighed in on whether the FDA can and should … Continue reading this entry

FDA Issues Draft Guidance for Clinical Trials Using Enrichment Strategies

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guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” (“Guidance Document”). The document is intended to provide guidance for … Continue reading this entry

Gene Patents and Diagnostics: The Economics of Innovation

The increasing importance of genetic markers and diagnostic tests in the drug approval process and the delivery of health care requires consideration of who will underwrite the necessary research and development, Michael Hopkins and Stuart Hogarth argue in the recent issue of Nature Biotechnology. “Biomarker patents for diagnostics: problem or solution?” Nature Biotechnology, Vol. 30(6): … Continue reading this entry

Personalized Medicine - Promise, Regulation and Challenges

Personalized Medicine seeks to individualize health care by identifying the most effective or most comfortable treatment for that individual.  Finding the right treatment for the right individual at the right time can be applied preventively or therapeutically to treat disease.  In one aspect of personalized medicine, an individual’s genetic code is analyzed and used to identify the … Continue reading this entry