Zdrowie i gospodarka · 19/10/1998

FDA Reopens Comment Period for Draft Guidance on ANDA Impurities in Drug Substances

The Food and Drug Administration (FDA) is extending the comment period for its draft guidance on ANDA impurities in drug substances until November 23, 1998, in response to industry requests for an extension, following the publication of a notice in the Federal Register on July 24, 1998.