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Zdrowie i gospodarka · 17/08/1999

Draft ``Guidance for Industry: Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act;'' Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act.'' This draft guidance is intended to provide guidance to industry on the use of certain types of letters by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) as part of the review of marketing applications for certain drug and biological products.

Source: Federal Register — Food and Drug AdministrationOpen original release →