Zdrowie i gospodarka · 24/07/1998

Draft Guidance for Industry on ANDA's: Impurities in Drug Substances; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA's: Impurities in Drug Substances.'' This draft guidance provides recommendations for including information in abbreviated new drug applications (ANDA's) and supporting drug master files on the content and qualification of impurities in drug substances produced by chemical syntheses for both monograph and nonmonograph drug substances.