CRG's Comments to FDA re Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology

by Administrator 21. November 2015 00:56
Federal docket number: FDA-2015-N-3403   COUNCIL FOR RESPONSIBLE GENETICS’ RESPONSES TO REQUEST FOR INFORMATION PUBLISHED AT 80 FED. REG. 60,414 – 60,416 (Oct. 6, 2015): “Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Reg... [More]

Are Your Medications Safe?

by jeeg 11. February 2015 01:09
  The FDA buries evidence of fraud in medical trials. My students and I dug it up. Agents of the Food and Drug Administration know better than anyone else just how bad scientific misbehavior can get. Reading the FDA’s inspection files feels almost like watching a highlights reel from ... [More]

FDA To Regulate Thousands Of Cancer, Genetic, And Other Diagnostics

by jeeg 4. August 2014 22:09
  The Food and Drug Administration unveiled plans to regulate thousands of diagnostic tests, including many coming from the exploding field of genetic research, to which it has until now turned a blind eye. More than 11,000 of these tests, known as laboratory-developed tests, created by 2,0... [More]

Empowering Consumers through Accurate Genomic Tests

by jeeg 1. July 2014 18:26
  We’ve come to recognize that almost every disease has a genetic component, and many consumers now are eager to know more about their genetic profiles. They need only send a sample of their DNA collected from their saliva or from a cheek swab to a company, and in exchange they&rsquo... [More]

A Baby with Three Parents?-CRG in the News

by jeeg 20. May 2014 02:14
  Danielle Messer is already a mother of two, but she wants another baby pretty badly. “Pretty badly might be an understatement,” Messer told America Tonight from her home in Kentucky. “I wanted a bigger family. I wanted a girl, really bad.” But the 36-year-old says... [More]

Direct-to-consumer genetic testing: a case of potential harm

by jeeg 8. May 2014 23:48
  Last November, the U.S. Food and Drug Administration issued a “cease and desist” order to 23andMe, a major purveyor of direct-to-consumer (DTC) genetic testing. In its letter to the company—issued after three prior warnings—the FDA reiterated its view that 23andM... [More]

FDA pushes DNA barcoding system adoption

by jeeg 23. April 2014 21:28
  The US Food and Drug Administration (FDA) is pushing adoption of its DNA barcoding system, which identifies individual fish species, in an effort to solve the species substitution problem in the United States. The system creates DNA barcodes to identify individual fish species, a project ... [More]

FDA wins high-profile support in consumer genetics kerfuffle

by jeeg 14. March 2014 21:20
  When the Food & Drug Administration last November ordered the Mountain View, Calif.-based firm 23andMe to stop marketing its health-related genetic test kit to consumers, the ensuing debate took on a "rage against the machine" tenor. Entrepreneurs, patients' rights advocates and geneti... [More]

U.S. stores say no to genetically engineered salmon. Someone has to.

by jeeg 12. March 2014 23:58
  The nation’s two largest conventional grocery chains, Kroger and Safeway, have announced that they will not sell genetically engineered salmon. They join several other chains, including Target, Whole Foods (of course) and Trader Joe’s. Now let’s hope the holdouts, such as... [More]

China Cracks Down on DNA Testing

by jeeg 4. March 2014 01:01
Genetic testing has grown to be a business big enough in China to warrant the government’s intervention. Early in February, the government quietly put the brakes on the provision of genetic tests to customers by domestic hospitals and a variety of medical and health institutions.   If... [More]
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