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Personalized Medicine

Discoveries facilitated by the mapping of the human genome and rapid technological advances in genomic sequencing and interpretation are leading to medical innovations that will have a significant impact on the practice of medicine and delivery of health care services. As personalized medicine is integrated into the mainstream practice of medicine, many health care policy questions must be answered.

Learn more about genomics and clinical practice

AMA comments to FDA re: Preliminary discussion paper “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests,” March 20, 2015

AMA comments to House Energy & Commerce on initial draft "21st Century Cures Act," February 23, 2015

AMA comments to FDA re: Framework for Regulatory Oversight of LDTs, February 2, 2015

AMA Statement for the Record to FDA re: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTS), January 8, 2015

AMA statement to Energy and Commerce re: 21st Century Cures: A Modernized Framework for Innovative Diagnostic Tests, January 5, 2015

Sign-on letter to FDA requesting withdrawal of proposed draft guidance on oversight of Laboratory Developed Tests, November 18, 2014

AMA letter to Energy and Commerce in response to its request for feedback on the 21st Century Cures initiative, September 26, 2014

AMA Statement for the Record re: 21st Century Cures: Examining the Regulation of Laboratory-Developed Tests, September 8, 2014