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FDA publishes draft guidance on reprocessing of reusable medical devices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The FDA has released for public comment a draft guidance document entitled "ProcessingReprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."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 to hold public workshop on reprocessing reusable medical devices (June 8)
  • Reed Smith LLP
  • USA
  • May 13 2011

On June 8, 2011, FDA will hold a "Reprocessing of Reusable Medical Devices Workshop."


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 solicits comments on effectiveness of regulations
  • Reed Smith LLP
  • USA
  • May 13 2011

Under Executive Order 13563, ''Improving Regulation and Regulatory Review,'' FDA is reviewing the effectiveness of the Agency's regulations in light of public health needs and advances in innovation."


FDA publishes final rule on constituent materials in biologics
  • Reed Smith LLP
  • USA
  • April 28 2011

The Food and Drug Administration (FDA) has published a final rule entitled "Revision of the Requirements for Constituent Materials."


FDA final guidance documents on writing requests for product designation
  • Reed Smith LLP
  • USA
  • April 28 2011

The FDA has released final "Guidance for Industry on How to Write a Request for Designation."


FDA issues guidance on manufacturing methodprocess changes
  • Reed Smith LLP
  • USA
  • April 28 2011

FDA has released a guidance document entitled "30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes."


FDA publishes final rule on constituent materials in biologics
  • Reed Smith LLP
  • USA
  • April 28 2011

The Food and Drug Administration (FDA) has published a final rule entitled "Revision of the Requirements for Constituent Materials."


FDA issues advanced notice of new GLP rules for non-clinical studies
  • Reed Smith LLP
  • USA
  • January 13 2011

Following a workgroup's conclusion that non-clinical studies should be conducted under a good laboratory practices (GLPs) quality system approach, FDA has decided to modify the existing GLP regulations for non-clinical studies


FDA draft guidance on electronic source documents in clinical trials
  • Reed Smith LLP
  • USA
  • January 13 2011

FDA has published a draft guidance entitled "Electronic Source Documentation in Clinical Investigations."