Legislation that would have accelerated the pace of federal drug approvals in a way that critics said threatened to erode patient safety was formally released this week, in a scaled-back version with many of the most controversial provisions left out.
The FDA April 8 released two final guidance documents that will help provide timely patient access to high-quality, safe and effective medical devices for unmet medical needs…Not everyone is pleased with the guidance, however.
The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) has expressed little confidence in genetic tests that supposedly predict common cancers. The decision raises doubts about whether the CMS will authorize Medicare coverage for such tests.
Medical Daily, March 18, 2015. French Government will now require breast implants to carry cancer warnings.
Time, February 19, 2015. Time Magazine asks us why close ties to industry is a problem for a new FDA Commissioner
Thanks to the Affordable Care Act, millions more Americans can now afford medical care that relies on devices like CT scans, cardiac implants or joint replacements. Our nonpartisan research center just released a report indicating that the device industry is thriving in the two years since the tax went into effect.