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Zdrowie i gospodarka · 3/16/2009

Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 197 entitled "Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files." The purpose of this draft guidance is to simplify the preparation and evaluation of submissions in support of new animal drug applications by providing a uniform system for documenting statistical analysis programs and data files.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →