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Zdrowie i gospodarka · 13.02.2009

Draft Guidance for Industry on Process Validation: General Principles and Practices; Reopening of Comment Period

The Food and Drug Administration (FDA) is reopening until March 16, 2009, the comment period for the draft guidance entitled "Process Validation: General Principles and Practices." FDA announced the availability of this draft guidance in the Federal Register of November 18, 2008 (73 FR 68431). The initial comment period closes on January 20, 2009. FDA is taking this action in response to a request for an extension of the comment period, due to the holiday season, to allow interested persons sufficient time to review this draft guidance and submit comments.

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