Zdrowie i gospodarka · 05/08/2008

FDA Releases Draft Guidance on Parametric Release of Sterile Drug Products

The FDA has made available a draft guidance document outlining recommendations for the submission of documentation in support of parametric release for human and veterinary drug products sterilized by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.