Oversight of Laboratory Developed Tests: Impact on Genomics?
FDA regulation of laboratory-developed diagnostic tests: Protect the public, advance the science.
Joshua Sharfstein, JAMA, January 5, 2015
Joshua Sharfstein, JAMA, January 5, 2015
Genetic testing and FDA regulation: Overregulation threatens the emergence of genomic medicine.
Evans J et al. JAMA January 5, 2015
Evans J et al. JAMA January 5, 2015
Q&A: FDA's Alberto Gutierrez fields questions on evolving LDT, CDx regulations![External Web Site Icon External Web Site Icon](https://lh3.googleusercontent.com/blogger_img_proxy/AEn0k_sxXumhA0XhqAQe-hpLoK75Gyq9-v-u71VvR2bJtPKvm5vpwZxiV8uusAW0r1K_c9XSTb6xnvITXkH9t7QIGC8PmczeMr6n8f0sHMejQSA3xtjWv6z8XY8r=s0-d)
Ray T. GenomeWeb, Dec 30, 2014.
Ray T. GenomeWeb, Dec 30, 2014.
Opinions divided on proposed FDA LDT regulations - The debate on laboratory developed tests boils down to whether clinical labs should come under the agency’s control,
by Chris Anderson, GEN & Biotechnology News, Jan 7, 2015
Check out our Laboratory Developed Tests update page for additional information and links
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