In 2015, the U.S. Food and Drug Administration (FDA) invited comment on its draft guidance for the regulatory oversight of laboratory-developed tests (LDTs). With a focus on genetic and genomic testing, ASHG submitted comments on the proposed regulatory oversight of such tests. Related: Comments Submitted in Response to FDA’s Draft Guidance: Framework for Regulatory Oversight... Read More
ASHG supports the teaching of evolution in public schools, and is disappointed by Tennessee’s enactment of a bill that weakens K-12 science instruction. House Bill 38, which became law in April 2012, undermined the teaching of evolution and several other scientific topics that form the basis of public scientific literacy. Related: ASHG Statement on Tennessee... Read More
In response to a 2011 request for information, ASHG submitted comments on the Advanced Notice of Proposed Rule Making for “Human Subjects Research Protection: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” The Society proposed adjustments to the review, approval, and follow-up for studies that will facilitate research and improve... Read More
In 2010, ASHG issued a policy statement outlining guiding principles related to patenting and licensing in the genetic testing arena. These principles address protection of intellectual property, quality of testing, and access to testing. Related: Guiding Principles on Protection of Intellectual Property: Patenting and Licensing in the Genetic Testing Arena (April 2010) Read More
After GINA’s passage in May 2008, ASHG responded to a Federal Register Request for Information on issues related to the law’s implementation. ASHG provided comment on definitions that would ensure the regulations keep pace with scientific and clinical advances, and clarified that data collected prior to GINA’s passage should still be covered by the law.... Read More