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]

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]

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]

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]

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]

“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]

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]

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]

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]

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]