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Results: 11-20 of 82

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FDA publishes draft guidance on reprocessing of reusable medical devices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The FDA has released for public comment a draft guidance document entitled "ProcessingReprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."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 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 issues final regulations requiring the submission of information on pediatric populations for devices
  • Reed Smith LLP
  • USA
  • April 16 2010

The Food and Drug Administration (FDA) has issued a direct final rule requiring sponsors of premarket approval applications (PMA), humanitarian device exemptions (HDE), and product development protocols (PDP) to submit data on pediatric populations for which the device is intended to treat diagnose, or cure, and the number of affected pediatric patients


FDA meeting on the development of drugbiological names, labels and packaging
  • Reed Smith LLP
  • USA
  • April 15 2010

FDA will hold a public meeting entitled "Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors" on June 24-25, 2010 in Bethesda, Maryland


FDA report on agency transparency with regulated industry
  • Reed Smith LLP
  • USA
  • January 13 2011

The FDA is seeking comments on a report entitled "FDA Transparency Initiative: Improving Transparency to Regulated Industry."