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Results: 11-20 of 82

FDA draft guidance on occurrence of suicidality in clinical trials
  • Reed Smith LLP
  • USA
  • September 17 2010

FDA has issued a draft guidance entitled "Suicidality: Prospective Assessment of Occurrence in Clinical Trials," which is intended to help sponsors to prospectively assess the occurrence of treatment-emergent suicidality in clinical trials of drug and biological products


FDA publishes draft guidance on reprocessing of reusable medical devices
  • Reed Smith LLP
  • USA
  • May 13 2011

The FDA has released for public comment a draft guidance document entitled "ProcessingReprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."


FDA reestablishes Medical Imaging Drugs Advisory Committee
  • Reed Smith LLP
  • USA
  • May 13 2011

FDA has announced the reestablishment of its Medical Imaging Drugs Advisory Committee (MIDAC


FDA guidance on medical device voluntary audit report submission program
  • Reed Smith LLP
  • USA
  • May 25 2010

FDA has issued draft guidance on the implementation of Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA


GAO report on drug safety oversight
  • Reed Smith LLP
  • USA
  • December 21 2009

A recent GAO report points to improvement in FDA’s postmarket drug safety oversight, but the agency expresses concern over continued gaps in particular areas


GAO issues two reports examining FDA foreign inspection issues
  • Reed Smith LLP
  • USA
  • October 28 2010

The Government Accountability Office (GAO) has issued two reports addressing foreign FDA inspectional issues


FDA workshop on medical device interoperability (Jan. 25-27)
  • Reed Smith LLP
  • USA
  • January 20 2010

An upcoming FDA public workshop will focus on safe and effective interoperable medical devices


FDA guidance document: planning for the effects of high absenteeism to ensure availability of medically necessary drug products
  • Reed Smith LLP
  • USA
  • January 13 2010

The FDA has issued a guidance document seeking to encourage the creation of contingency production plans for the manufacture of medically-necessary drug products and their components during emergencies that result in high absenteeism at production facilities


FDA public meeting and comment request on incorporation of new science into CDRH regulatory decision making (Feb. 9, 2010)
  • Reed Smith LLP
  • USA
  • December 21 2009

FDA is holding a public meeting on February 9, 2010 to discuss measures for incorporating new science (i.e., novel technologies or novel uses of existing technologies, evolving information and knowledge, or new methods to support decision making) into the FDA Center for Devices and Radiological Health decision-making processes


FDA seeks comments on draft guidance concerning drug development tools
  • Reed Smith LLP
  • USA
  • October 28 2010

The Food and Drug Administration (FDA) has issued for public comment a draft guidance entitled "Qualification Process for Drug Development Tools."