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FDA Guidances for Early Human Testing of New Drugs

FDA Guidances for Early Human Testing of New Drugs

Officials of the National Cancer Institute have welcomed two new guidance documents issued by the US Food and Drug Administration (FDA). The two aim at making it easier for clinical researchers to conduct small-scale human studies of exploratory drugs prior to phase I trials. The documents are designed to increase the number of promising drugs that researchers can evaluate by administering them at microdose levels to small numbers of patients before deciding whether the agents warrant further human study.

The Exploratory IND Studies guidance addresses safety tests, manufacturing, and clinical approaches to conducting very early human testing to determine a drug's distribution and activity in the human body. It advises researchers how they can take advantage of the flexibility in FDA regulations when they seek the agency's approval to proceed with such a study.

The second guideline describes an approach researchers can take that will satisfy the agency's Current Good Manufacturing Practice requirements related to drugs intended solely for use in phase I studies. This guidance will enable researchers to evaluate investigational drugs without expending time and money to show they have the capacity to produce the drugs on a large scale.

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