Zdrowie i gospodarka · 05/01/1999

Draft Guidance for Industry on SUPAC-SS: Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``SUPAC-SS: Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum.'' This draft guidance is intended to provide recommendations to pharmaceutical manufacturers using the Center for Drug Evaluation and Research's guidance for industry, ``SUPAC-SS Nonsterile Semisolid Dosage Forms, Scale-Up and Post Approval Changes: Chemistry Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation'' (SUPAC-SS).