FDA Issues Guidance On Biotech Pharmaceutical Testing

Law360, New York (May 18, 2012, 5:15 PM EDT) -- The U.S. Food and Drug Administration on Thursday released new guidance for early-stage testing of biotech drugs, clarifying and revising advice intended to avert serious side effects and minimize animal testing.

The nonbinding recommendations, which update standards issued in the 1990s, relate to a long-standing effort at harmonizing clinical development taking place in the U.S., Europe and Japan.

Topics include proper selection of animal species for pharmaceutical testing, design of preclinical studies, measurement of immune system response, evaluation of cancer risks and screening of effects on...
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