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Results: 1-10 of 41

FDA Announces Plans to Improve Safety and Advance Innovation of Medical Devices
  • Reed Smith LLP
  • USA
  • April 18 2018

On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (Action Plan


Is Your Software a Medical Device? FDA Weighs-in with New Draft Guidances
  • Reed Smith LLP
  • USA
  • December 19 2017

On December 8, 2017 - nearly a year after President Obama signed into law the 21st Century Cures Act ("Cures Act") - the Food and Drug Administration


FDA Issues Draft Guidance on Labeling For Biosimilar Products
  • Reed Smith LLP
  • USA
  • April 12 2016

The federal Food and Drug Administration ("FDA") recently published a draft guidance on labeling for biosimilar products that is intended to assist


FDA announces medical device user fee rates for fiscal year 2016
  • Reed Smith LLP
  • USA
  • August 6 2015

Earlier this week, the Federal Food and Drug Administration (FDA) issued a notice in the Federal Register (80 Fed. Reg. 46033) announcing the fee


FDA final rule mandates drug manufacturer notification of impending drug shortages
  • Reed Smith LLP
  • USA
  • July 17 2015

On July 8, 2015, the federal Food and Drug Administration (FDA) published a final rule requiring drug manufacturers to report to the Agency any supply


FDA issues three biosimilar final guidances
  • Reed Smith LLP
  • USA
  • May 8 2015

On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances


FDA releases draft guidance on acceptance of medical device clinical data from studies conducted abroad
  • Reed Smith LLP
  • USA
  • April 23 2015

On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the


FDA one step closer to new direct-to-consumer television ad requirements
  • Reed Smith LLP
  • USA
  • January 14 2015

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television


FDA releases two draft guidance documents on proposed Laboratory Developed Test (LDT) regulatory oversight
  • Reed Smith LLP
  • USA
  • October 8 2014

On September 30, 2014, the Food and Drug Administration (FDA) announced the availability of two draft guidances intended to implement a new


FDA seeks comments to updated guidance on informed consent in clinical trials
  • Reed Smith LLP
  • USA
  • August 26 2014

Earlier this summer, the Food and Drug Administration (FDA) issued a draft 42-page "Informed Consent Information Sheet" that provides guidance for