We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 11-20 of 82

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 public workshop on Sentinel Initiative (Jan. 12)
  • Reed Smith LLP
  • USA
  • December 14 2010

FDA is holding its third annual public workshop on the Sentinel Initiative on January 12, 2011


FDA seeks comments on clinical benefit information in professional labeling, direct-to-consumer print advertisements
  • Reed Smith LLP
  • USA
  • December 15 2010

FDA has announced plans to conduct a study entitled "Clinical Benefit Information in Professional Labeling and Direct-to-Consumer Print Advertisements for Prescription Drugs."


FDA issues guidance on public input portion of advisory committee meetings
  • Reed Smith LLP
  • USA
  • December 15 2010

A new FDA publication, "Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings," is intended to inform the public how they may participate at an open public hearing session of advisory committee meetings


FDA requests notification of intent to participate in medical device user fee reauthorization process
  • Reed Smith LLP
  • USA
  • December 15 2010

FDA has published a notice requesting that patient and advocacy groups notify FDA by January 6, 2011 if they intend participate in a series of public meetings on reauthorization of medical device user fees


FDA issues draft guidance document on manufacturer communications to health care providers
  • Reed Smith LLP
  • USA
  • November 29 2010

FDA has released for comment a draft guidance document entitled, "Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information."


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 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