21st Century Cures

  • Read more: Sharing Data for 21st Century Cures – Two Steps Forward…
    Article

    Sharing Data for 21st Century Cures – Two Steps Forward…

    By Mary A. Majumder, Christi J. Guerrini, Juli M. Bollinger, Robert Cook-Deegan, and Amy L. McGuire The 21st Century Cures Act was passed with support from both sides of the aisle (imagine that!) and signed into law by then-President Obama late last year. This ambitious legislation drives action in areas as diverse as drug and…

  • Read more: House Hearing on Regulation of Laboratory-Developed Tests Displays More Consensus Than Disagreement
    Article

    House Hearing on Regulation of Laboratory-Developed Tests Displays More Consensus Than Disagreement

    By Rachel Sachs The Health Subcommittee of the House Energy & Commerce Committee held a hearing last week on the FDA’s proposed draft guidance regarding laboratory-developed tests (LDTs), as part of its “21st Century Cures” initiative. The hearing, which can be viewed online (here and here), featured representatives from the FDA, industry, and research organizations….