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The Food and Drug Administration (FDA) today announced steps to advance the earliest phases of clinical research in the development of innovative medical treatments. FDA’s goal is to improve the process for bringing safe and effective drugs for potentially serious and life-threatening diseases, such as cancer, heart disease and neurological disorders, to the market.
In guidance documents released today, Exploratory IND Studies and INDs—Approaches to Complying with CGMP During Phase 1, the FDA lays out specific approaches for researchers who are planning to conduct very early clinical studies in people and offers approaches for performing appropriate safety testing and producing small amounts of drugs safely. In line with the aims of FDA’s Critical Path Initiative to modernize the drug development process, these changes will enable U.S. medical researchers to evaluate much more efficiently the promise of scientific advances discovered in their laboratories.
“Currently, nine out of ten experimental drugs fail in clinical studies because we cannot accurately predict how they will behave in people based on laboratory and animal studies,” said Health and Human Services Secretary Mike Leavitt. “The recommendations announced today will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs.”
The Exploratory IND Studies guidance will facilitate very early exploratory scientific studies in people before the standard safety studies (phase 1) begin. Because only small amounts of drugs are used in these early studies, they represent fewer potential risks for people in these trials. In the final version of the guidance Exploratory IND Studies, FDA makes recommendations about safety testing, manufacturing, and clinical approaches that can be used in these very early studies. The guidance explains how medical researchers can take full advantage of the flexibility built into existing regulations in the amount of data needed when asking the FDA’s permission to proceed with such a study, enabling more rapid delivery of innovative products to patients.
“One of the biggest barriers research and academic institutions face is the ability to get discoveries made in the lab into clinical testing. The new Exploratory IND guidance emphasizes the flexibility available to researchers when conducting early clinical testing of these cutting-edge treatments,” said Andrew von Eschenbach, MD, Acting FDA Commissioner of Food and Drugs. “As we enter the era of personalized medicine, these exploratory approaches enable scientists to take full advantage of new technologies to target the development of more individualized therapies.”
In related draft guidance, INDs—Approaches to Complying with CGMP During Phase 1, the FDA outlines a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended for use solely in phase 1 studies. With this new guidance and an accompanying regulation, FDA formally recognizes specific standards for the manufacture of small amounts of drug product for phase 1 studies and formulating an approach to cGMP compliance that is appropriate for the particular stage of drug development.
“The problem is that researchers conducting very early studies were required to follow the same manufacturing procedures as those companies that mass produce products for broad scale distribution," said Janet Woodcock, MD, FDA Deputy Commissioner for Operations. "These requirements are so burdensome for early phase 1 studies that many leading medical research institutions have not been able to conduct these studies of discoveries made in their laboratories. Today, for the first time, medical researchers are getting specific advice from the FDA about how to safely prepare products for exploratory studies."
The documents released today are part of FDA’s commitment to modernize existing CGMP regulations to streamline clinical development. These efforts are part of the Agency’s Critical Path Initiative, launched in a March 2004. The goal of the Critical Path Initiative is to reduce the time and resources expended on candidate products that are unlikely to succeed, by creating new tools to distinguish earlier in the process those candidates that hold promise.
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Direct Final Rule: Current Good Manufacturing Practice Regulation and Investigational New Drugs
http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0285-nfr0001.pdf
Exploratory IND Studies
http://www.fda.gov/cder/guidance/7086fnl.htm
Federal Register
http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0122-nad0001.pdf
INDs — Approaches to Complying with CGMP During Phase 1
http://www.fda.gov/cder/guidance/6164dft.htm
Federal Register
http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0286-nad0001.pdf
Acting Commissioner's Remarks (Jan. 12, 2006)
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