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FDA Issues Draft Guidance on Providing More Information on Investigational Treatment

Posted on: 02/04/2004

FDA Issues Draft Guidance on Providing More Information on Investigational Treatment

January 27, 2004
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The Food and Drug Administration (FDA) today issued a draft guidance designed to make further information about the use of investigational drugs more readily available (see links below).

Clinical trials are research studies designed to test the safety and effectiveness of new therapeutic agents. Sometimes, however, patients with serious or life threatening diseases cannot be treated with existing therapy, or they do not meet the eligibility criteria for enrollment, or they are otherwise unable to participate in a controlled clinical trial. In these situations, when companies are willing, there are a number of programs FDA has in place which allow patient's access outside the clinical trial setting to promising therapies.

The draft guidance is part of the Best Pharmaceuticals for Children Act (Public Law 107-109) (BPCA), and is designed to augment information available in the Clinical Trials Data Bank ( Clinical was developed by the National Library of Medicine following passage of the Food and Drug Administration Modernization Act of 1997. It is a publicly available Internet data bank providing information on clinical trials of drug and biological therapies sponsored by the private sector as well as studies sponsored by the National Institutes of Health and other government agencies.

The new information required by the BPCA includes a description of whether, and through what procedure, the sponsor of the research will respond to requests for access to the therapy outside of the clinical trial setting, particularly in children. This draft guidance explains how to provide that information in a straightforward and efficient way.

"This FDA guidance promises to get more information to patients that really need it," said Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. "It represents our continuing effort to work with the private sector to provide information for patients about new treatments in development for serious or life threatening diseases." is the world's largest source of clinical trial information -- currently listing approximately 9,100 federally and privately sponsored trials throughout the United States and abroad - and has proved to be a very useful resource for patients seeking information on clinical trials testing promising therapies for their medical conditions.

The draft guidance will be posted in the Federal Register on January 27, 2004 with a comment period of 60 days. Those interested in submitting written comment can send them to the following address:

Division of Dockets Management (HFA)
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Further information about clinical trials of medical products is available on FDA's Web site at

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