F.D.A. Weighs Fertility Method That Raises Ethical Questions

by jeeg 26. February 2014 19:47
The Food and Drug Administration is weighing a fertility procedure that involves combining the genetic material of three people to make a baby free of certain defects, a therapy that critics say is an ethical minefield and could lead to the creation of designer babies. The agency has asked a pane... [More]

FDA weighs risks of 3-person embryo fertilization

by jeeg 26. February 2014 19:43
Should doctors be allowed to tinker with genes to produce a healthy baby? That's the question a Food and Drug Administration panel will consider this week when it holds hearings on whether to allow a controversial fertility technique to be tested on women with mitochondrial disease. The field's ... [More]

Genetic Testing Needs a Nudge

by jeeg 24. February 2014 18:35
Mail-away genetic testing promises to revolutionize the way that people learn about and manage their health. Already half a million Americans have sent their saliva to find out their risk of genetic disease -- no doctors needed. Splashed across TV sets nationwide this past summer was 23andMe's in... [More]

Genetically Modified Babies

by jeeg 24. February 2014 18:21
An advisory committee of the Food and Drug Administrationis set to begin two days of meetings tomorrow to consider radical biological procedures that, if successful, would produce genetically modified human beings. This is a dangerous step. These techniques would change every cell in the bodi... [More]

FDA Asked to Approve Creation of Genetically Modified Children

by jeeg 21. February 2014 01:23
In a public meeting scheduled for February 25-26, the U.S. Food and Drug Administration (FDA) will consider approval of experiments to produce children by the in vitro fertilization of an egg containing DNA derived from both the intended mother and another woman. Although such large-scale geneti... [More]

Genetics for the People?

by jeeg 7. February 2014 22:59
“Your genetic information should be controlled by you,” declares an advertisement for the American direct-to-consumer (DTC) genetic-testing firm 23andMe. Amid the current furor over electronic eavesdropping, the notion that individuals should decide who can access their personal data i... [More]

Appeals Court Says Stem Cells May be Regulated as Drugs, Affirming Low Court's Decision

by jeeg 6. February 2014 20:40
The US District Court of Appeals for the DC Circuit has ruled that a lower court was correct when it ruled that the US Food and Drug Administration (FDA) could legally regulate stem cells as drugs. Background In July 2012, the US District Court of DC ruled that FDA may legally regu... [More]

Direct-to-Consumer Testing’s Constitutional Appeal

by jeeg 5. February 2014 20:43
The First Amendment may not protect someone yelling “Fire!” in a crowded theater, but should shield 23andMe and other direct-to-consumer (DTC) genetic testing companies from “overcautious” FDA regulation, two longtime supporters of test providers argue, reopen... [More]

FDA: Courts on Their Own in GMO "All Natural" Lawsuits

by jeeg 30. January 2014 22:13
The U.S. Food and Drug Administration (FDA) declined to decide whether food may be labeled "Natural", "All Natural" or "100% Natural" if it contains bioengineered ingredients, putting the onus on the federal district courts in litigation that has sprung up across the United States. ... [More]

How FDA and 23andMe Dance Around Evidence That Is Not There

by jeeg 28. January 2014 22:02
On July 20, 2010, Andrew Alexander, founder and director of easyDNA, received a letter from the US Food and Drug Administration. The FDA had noticed that easyDNA was marketing the "Genetic Predisposition Health Test, a home-use device that is intended to allow individuals to discover whether t... [More]
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