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US FDA amends preclinical testing requirements for biotech drugs

21-May-2012

US FDA amends preclinical testing requirements for biotech drugs

The US FDA has updated its preclinical testing requirements for biotech drugs citing advances since the publication of ICH S6 and the need to harmonize with international standards.

The amendment is designed to clarify the agency’s position on species selection, study design, immunogenicity, reproductive and developmental toxicity, as well as the assessment of candidate drug’s carcinogenic potential.

In an accompanying statement the US Food and Drug Administration (FDA) said: “This guidance should facilitate the timely conduct of clinical trials, reduce the use of animals in accordance with the 3Rs [reduce/refine/replace] principles and reduce the use of other drug development resources.”

The agency also advised that drugmakers should consider using appropriate in vitro alternative testing methods for safety evaluation if at all possible.

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