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Zdrowie i gospodarka · 9.12.2014

Two-Phased Chemistry, Manufacturing, and Controls Technical Sections; Draft Guidance for Industry; Extension of Comment Period

The Food and Drug Administration (FDA) is extending the comment period for a notice of availability of draft guidance for industry (GFI #227) entitled "Two-Phased Chemistry, Manufacturing, and Controls Technical Sections" that appeared in the Federal Register of October 20, 2014. In that notice, FDA made available for comment the draft guidance, which provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

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