Chemistry, Manufacturing, and Controls Technical Section Filing Strategies; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #227 entitled "Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies." This draft guidance provides recommendations to sponsors submitting CMC data submissions to new animal drug applications. This guidance describes the options for soliciting early input from the Center for Veterinary Medicine (CVM) and the process for submission of components of the CMC technical section.
Abstract as published in the Federal Register.
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