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Results: 11-20 of 82

FDA’s emerging internet policy: themes and recommendations from public hearing on promotion of FDA-regulated medical products using the internet and social media tools
  • Reed Smith LLP
  • USA
  • November 27 2009

Following a decade-long hiatus, the Food and Drug Administration ("FDA") appears ready to finally address industry Internet communications


FDA issues warning letters to web site operators
  • Reed Smith LLP
  • USA
  • December 4 2009

On November 19, 2009, FDA completed a coordinated and collaborative international effort intended to curb illegal actions involving medical products sold via the internet


FDA announces Safe Use initiative for drug products
  • Reed Smith LLP
  • USA
  • December 4 2009

The Food and Drug Administration (FDA) has announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use


FDA guidance documents
  • Reed Smith LLP
  • USA
  • December 4 2009

FDA released a number of final and draft guidance documents in November, including the following


Public hearing on promotion of FDA-regulated medical products using the internet and social media tools
  • Reed Smith LLP
  • USA
  • December 4 2009

The FDA recently held a hearing to help the agency determine how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the internet and newer technologies


FDA announces medical device user fees for FY 2011, upcoming meeting (Sept. 12)
  • Reed Smith LLP
  • USA
  • August 13 2010

FDA announced the medical device user fees for FY 2011, which covers October 1, 2010 - September 20, 2011


FDA meeting and request for comments on generic drug user fee program
  • Reed Smith LLP
  • USA
  • August 13 2010

FDA will hold a public meeting on September 17, 2010 to seek input on the development of a generic drug user fee program


CDRH announces 2010 Compliance Strategic Plan
  • Reed Smith LLP
  • USA
  • August 13 2010

The CDRH has released its 2010 Compliance Strategic Plan


Memorandum of understanding between FDA and CMS
  • Reed Smith LLP
  • USA
  • August 13 2010

The FDA and CMS have entered into a Memorandum of Understanding (MOU), effective June 25, 2010, to promote collaboration and enhance knowledge and efficiency by sharing information and expertise


FDA proposes changes to the 510(k) program; seeks public comment
  • Reed Smith LLP
  • USA
  • August 13 2010

FDA has made available for comment two reports from internal agency workgroups, one from the Center for Devices and Radiological Health (CDRH) 510(k) Working Group, and another from the Task Force on the Utilization of Science in Regulatory Decision Making