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FDA issues draft biosimilars guidance, gaps leave practitioners wondering
  • Shook Hardy & Bacon LLP
  • USA
  • February 16 2012

The Food and Drug Administration (FDA) has issued three draft guidance documents to implement health-care reform law provisions requiring the creation of an abbreviated approval pathway for biological products that are similar to an FDA-licensed biological product.


Lawmakers introduce bill to expedite FDA’s medical device review process
  • Shook Hardy & Bacon LLP
  • USA
  • October 20 2011

U.S. Senators Amy Klobuchar (D-Minn.), Richard Burr (R-N.C.) and Michael Bennet (D-Colo.) have introduced a bill (S. 1700) aimed at reducing “regulatory burdens that unnecessarily delay new medical devices from reaching the market.”


IOM deems 510(k) medical-device clearance process flawed; FDA seeks comments
  • Shook Hardy & Bacon LLP
  • USA
  • August 4 2011

The Institute of Medicine (IOM) has issued a report titled “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years,” calling for an overhaul of Food and Drug Administration (FDA) procedures for approving medical devices that are considered a moderate risk to patients and are substantially equivalent to any previously cleared device or one that was on the market before the Medical Device Amendments were enacted in 1976.