FDA Plans to Regulate New Genetic Tests
FDA Plans to Regulate New Genetic Tests
The New York Times reports today (9/6/06) that the Food and Drug Administration is planning to regulate certain types of genetic tests:
http://www.nytimes.com/2006/09/06/business/06drug.html?_r=1&oref=slogin
FDA has published the proposed new policy and is accepting public comment.
FDA already regulates test kits that are sold to labs, hospitals, and physicians, but it does not regulate “home brew” tests that are developed and used within a single laboratory. Only a small number of tests are currently in use, but the number is expected to grow rapidly.
A thorough discussion of this issue can be found in the Spring 2006 Issues in Science and Technology (“Federal Neglect: Regulation of Genetic Testing” by Gail H. Javitt and Kathy Hudson of Johns Hopkins University) at http://www.issues.org/22.3/javitt.html.
The New York Times reports today (9/6/06) that the Food and Drug Administration is planning to regulate certain types of genetic tests:
http://www.nytimes.com/2006/09/06/business/06drug.html?_r=1&oref=slogin
FDA has published the proposed new policy and is accepting public comment.
FDA already regulates test kits that are sold to labs, hospitals, and physicians, but it does not regulate “home brew” tests that are developed and used within a single laboratory. Only a small number of tests are currently in use, but the number is expected to grow rapidly.
A thorough discussion of this issue can be found in the Spring 2006 Issues in Science and Technology (“Federal Neglect: Regulation of Genetic Testing” by Gail H. Javitt and Kathy Hudson of Johns Hopkins University) at http://www.issues.org/22.3/javitt.html.
posted by Kevin Finneran at
1:18 PM
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