Posts Tagged ‘Food and Drug Administration’

  • Lawmakers bid to close loopholes on malfunctioning med devices Wednesday, February 8, 2012 � by eric

    More than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to being cleared by the FDA for distribution or sale.

  • Conflicts of interest reported for FDA panel that signed off on Yaz birth control drug Wednesday, January 11, 2012 � by jg

    Washington Monthly blog: An investigation by journalists found some members of a U.S. Food and Drug Administration committee of medical experts that looked into the potential dangers of the Bayer birth control pills Yaz and Yasmin had potential conflicts of interest.

  • FDA advisers recommend stronger warnings for Yaz, Yasmin birth control pills Friday, December 9, 2011 � by jg

    Washington Post: Members of two U.S. Food and Drug Administration committees voted that the labels now on the pills don’t provide adequate warning about the pills’ potential for causing blood clots.

  • Former FDA head says Bayer withheld data about Yasmin Monday, December 5, 2011 � by jg

    Bloomberg: David Kessler says in court documents that the pharmaceutical giant withheld information that users of the company’s Yasmin birth control pills had increased reports of blood clots.

  • Tainted wipes may have led to fatal infection Tuesday, February 15, 2011 � by jg

    MSNBC: The parents of a 2-year-old boy who died after contracting a fatal infection in a Houston hospital are suing the makers of alcohol wipes that were later recalled for possible contamination with the same bacteria that killed the boy.

  • Lack of testing leads to medical device recalls Tuesday, February 15, 2011 � by jg

    New York Times: A new study found that “most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway that requires little, if any, testing.”

  • Makers of POM Wonderful sued for claiming health benefits Wednesday, August 18, 2010 � by jg

    Courthouse News Service: A class action lawsuit filed in Florida stems from what the plaintiffs describe as an “extensive and comprehensive marketing campaign.”