Single Dose Acute Toxicity Testing

Consensus Regarding new Drug Applications. " The Agency has revised this guidance based on comments it received on the proposed implementation. This approach, designed to facilitate the early stages of pharmaceutical development, is not and ICH consensus position although it is considered to be in general agreement with the ICH position on acute toxicity testing. This guidance was published in the Federal Register on August 26, 1996 (61 FR 43934). Although this guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the industry, it does represent the Agency's current thinking on single dose acute toxicity testing for pharmaceuticals.