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FDA Guidance for Industry: Established Conditions: Rportable CMC Changes for Approved Drug and Biologic Products

Origin/Publisher:

FDA

Content:
This guidance has been developed to address the lack of clarity with respect to what chemistry, manufacturing, and controls (CMC) information in a marketing application constitutes an established condition or a “regulatory commitment” that, if changed following approval, requires reporting to FDA

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GMP Conferences by Topics

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