The Food and Drug Administration (FDA) announced steps to advance the earliest phases of clinical research in the development of innovative medical treatments. This should make it easier for universities and small drug companies to test promising therapies in humans without having to pay the enormous amounts of expenditures normally required.

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, the FDA says 9 of 10 experimental drugs fail in clinical testing that can cost companies millions. And many experimental drugs go untested in humans because the current system requires massive investments before the make-or-break stage of drug development.

The FDA approved only 20 new drugs last year and, from 2002 to 2004, newly approved drugs took an average of 8.5 years for approval. If the length of clinical trials were shaved by one-quarter, drug manufacturers would save $129 million while halving the time spent on clinical trials would lower drug development costs by 29 percent, saving drug companies $235 million.

In related draft guidance, INDs-Approaches to Complying with CGMP During Phase 1, the FDA outlines a suggested approach to complying with current good manufacturing practice (CGMP)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.

Direct Final Rule: Current Good Manufacturing Practice Regulation and Investigational New Drugs

Exploratory IND Studies

Federal Register

INDs — Approaches to Complying with CGMP During Phase 1

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