Zdrowie i gospodarka · 23/09/2011

Guidance for Industry on Reproductive and Developmental Toxicities-Integrating Study Results To Assess Concerns; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Reproductive and Developmental Toxicities--Integrating Study Results to Assess Concerns." This guidance describes an approach to estimating possible human developmental or reproductive risks associated with drug or biological product exposure when a nonclinical finding of toxicity has been identified, but definitive human data are unavailable. The guidance is intended for drug developers planning to submit new drug applications (NDAs) and biologics licensing applications (BLAs), and who are assessing nonclinical toxicity information.