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Posts published in “Premarket Approval – PMA”

USFDA Final Guidance – Manufacturing Site Change Supplements: Content and Submission

Manufacturing Site Change Supplements: Content and Submission; Guidance for Industry and Food and Drug Administration Staff; Availability https://www.federalregister.gov/documents/2018/12/17/2018-27237/manufacturing-site-change-supplements-content-and-submission-guidance-for-industry-and-food-and-drug