In May 2012, FDA recently updated its requirements under ICH S6 Guidance for its preclinical testing of biotech drugs. To view this amendment, click here. Along with notable advances and the need to harmonize with international standards, the amendment states that its purpose is to reiterate and clarify the topics of species selection, study design, immunogenicity, reproductive and developmental toxicity, and the assessment of carcinogenic potential.

This update also mentions FDA’s suggestion to reduce the use of animals in preclinical trials and instead consider the use of appropriate in vitro testing methods if possible. To read more coverage on this topic, see this article, and to see the ICH S6 amendment on the FDA website, click here.