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Results: 11-20 of 82

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 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FDA publishes draft guidance on reprocessing of reusable medical devices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The FDA has released for public comment a draft guidance document entitled "ProcessingReprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."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 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 debarment and disqualification processes
  • Reed Smith LLP
  • USA
  • October 30 2009

The GAO issued a report entitled "Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Medical Product Investigators."


Sebelius issues Section 1135 waiver
  • Reed Smith LLP
  • USA
  • October 29 2009

On October 24, 2009, President Obama signed a proclamation declaring the 2009 H1N1 influenza pandemic a National Emergency to facilitate the nations ability to respond to the H1N1 pandemic by enabling if warranted the waiver of certain statutory federal requirements for medical treatment facilities


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