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New FDA recommendations to speed drug development

On 12 January 2006, the US Food and Drug Administration (FDA) released guidance documents to help scientists speed the development of new medical treatments in clinical research, in an effort to accelerate the process by which new drugs are brought to market for potentially serious and life-threatening diseases of human patients1,2,3.

In the first document, the FDA advises scientists who plan to conduct very early clinical studies in people on how to perform appropriate safety tests and produce small amounts of drugs safely, flexibly, and efficiently4. The second document provides guidance on how to comply with current good manufacturing practice (CGMP) requirements for drugs undergoing early (Phase 1) safety studies5.

Health and Human Services Secretary Mike Leavitt stated that “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.” The new FDA recommendations, he said, “will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs1.”

According to Janet Woodcock, MD, FDA Deputy Commissioner for Operations, these new guidances will help researchers who conduct small studies to overcome the burdensome requirements for early Phase 1 studies, which previously required such investigators to implement the same procedures as manufacturers who produce and distribute large amounts of medicines1


  1. FDA. FDA issues advice to make earliest stages of clinical drug development more efficient. (12 January 2006).

  2. FDA. Direct final rule. Current good manufacturing practice regulation and investigational new drugs. Federal Register 71(10), 2458–2462 (17 January 2006).

  3. FDA. FDA teleconference: steps to advance the earliest phases of clinical research in the development of innovative medical treatments. (12 January 2006).

  4. FDA. Guidance for industry, investigators, and reviewers: exploratory IND studies. (January 2006).

  5. FDA. Guidance for industry: INDs—approaches to complying with CGMP during Phase 1. (January 2006).

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Shalev, M. New FDA recommendations to speed drug development. Lab Anim 35, 13 (2006).

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