Zdrowie i gospodarka · 26/02/2010

FDA Releases Guidance on Parametric Release of Sterilized Drug Products

The Food and Drug Administration (FDA) has made available a guidance document outlining recommendations for submitting documentation to support parametric release of human and veterinary drug products sterilized by moist heat, applicable to new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated new animal drug applications, and biologics license applications.