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GCP Update from FDA September 25, 2010

Posted by Michael Hamrell in Regulatory Thoughts.

In September 2010 the FDA issued an update on the accomplishments and status of various initiatives related to good clinical practice and human subject protection. This is an update to the first progress report issued in January 2009. The report highlights accomplishments and progress since the first report.

Listed below is a summary of some of the items that FDA featured about their accomplishments.

  • New Regulations – Five new final or proposed regulations
  • New Guidance – Five new guidance documents
  • Improvements to FDA’s Internal Procedures – four proposal and plans to improve the clinical trial oversight
  • Clinical Trial Transformation Initiative (CTTI) – Five programs as part of the initiative that is a cooperation between FDA and Duke University
  • International Harmonization, Capacity-Building, and Outreach Activities – this section highlights a number of meetings and programs to extend FDA’s cooperation with regulatory authorities in other countries. In particular, the joint EMA-FDA inspection program for GCP studies is mentioned
  • Guidance in Development – Five new or revisions to existing guidance documents in development. This includes an updated guidance on informed consent and financial disclosure. No date is given for release of the various documents
  • Modernizing FDA Regulations – Four proposed updates to existing regulations, including IND safety reporting and international clinical trials for medical devices and an update to the GLP regulations, which were finalized in 1978 and have not been substantially updated in over 30 years.
  • For a complete copy of the report go to this link:



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