Zdrowie i gospodarka · 27/08/1999

Draft Guidance for Industry on ANDA's: Blend Uniformity Analysis; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA's: Blend Uniformity Analysis.'' This draft guidance is intended to provide recommendations to holders of abbreviated new drug applications (ANDA's) on establishing in-process acceptance criteria related to blend uniformity analysis (BUA) for the manufacture of some drug products.