Policy & Advocacy News

January 18, 2017 – (FDA) – Recent scientific advances now make it possible to more efficiently and precisely alter the genome of plants, animals, and microorganisms to produce desired traits. These genome editing technologies are relatively easy to use and can be applied broadly across the medical, food and environmental sectors, with potentially profound beneficial effects on human and animal health. 
August 29, 2016 – (Wall Street Journal) – In two days of hearings next month, the U.S. Food and Drug Administration will consider if clinics offering stem-cell treatments should be more closely regulated.
July 12, 2016 – (NASEM) – The event featured several speakers focusing on social issues, including race and genetics in US history, and the intersection of moral views and public policy. 
July 5, 2016 – (Nature) – US regulators must regain the upper hand in the approval system. 
January 14, 2016 – (Senator Tammy Baldwin) – U.S. Senator Tammy Baldwin has introduced legislation that would direct the U.S. FDA to facilitate the establishment of a public-private Standards Coordinating Body in Regenerative Medicine. The Advancing Standards in Regenerative Medicine Act also directs FDA to participate in developing such standards and to issue guidance on how these standards could be used in FDA review of regenerative medicine products.
December 16, 2015 – (RAPS) – Congress is also taking note of new genome-editing tools and it seems to be taking a cautious approach. The omnibus bill includes a provision that prevents FDA from reviewing applications related to genome-editing tools to modify the DNA of human embryos “until serious and unquantifiable safety and ethical issues can be resolved.”
October 26, 2015 – (EMA) – The PRIME scheme will aim to strengthen support to medicines that have the potential to benefit patients who presently have no treatment options, or that may offer a major therapeutic advantage over existing treatments. The document is open for consultation, deadline for comments is December 23, 2015.