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Regulations & Regulatory Advocacy


This section includes relevant regulations from the Federal Agencies with oversight of clinical trials and any background materials that may accompany the regulations.  You can also find letters to and from these Federal Agencies regarding clinical trials.

The following are comments and responses that ASCO has submitted regarding clinical trials.  This list will be updated as more comments are filed.

Dear Colleague Letter from Senator Kennedy and Senator Hutchison regarding the 21st Century Cancer ALERT Act of 2009 (S.717)

21st Century Cancer ALERT (Access to Life-Saving Early detection, Research and Treatment) Act of 2009 (S.717)

ASCO Written Testimony to Alaska in Support of Legislation That Would Require Insurers to Provide Coverage to Patients Participating in Cancer Clinical Trials - February 2009

ASCO and Leukemia and Lymphoma Society Letter Supporting Federal Employee Clinical Trials Coverage - September 2008

Cancer Leadership Council Letter of Endorsement for Cancer Clinical Trials Act - June 2008

ASCO's Letter to NCI on the First Generation Guidelines for NCI-Supported Biospecimen Repositories - June 2006

FDA Draft Guidance on Patient-Reported Outcome Measures - April 2006

NCI Translational Research Working Group - January 2006

NCI's Response to ASCO's Comments Regarding the Translational Research Working Group - March 2006

OHRP Draft Guidance on Reporting Serious Adverse Events - January 2006

NIH Plan to Recognize Multiple PIs on Grant Applications - September 2005

FDA Draft Guidance on Clinical Trial Endpoints - June 2005

ASCO Letter to CMS on Medicare Clinical Trials Coverage Policy Reconsideration - July 2004 




 
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