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NDA/ANDA changes

This article was originally published in The Tan Sheet

Executive Summary

FDA guidance entitled "Changes to an Approved NDA or ANDA" published in the Nov. 23 Federal Register; copies are available on the agency's Web site (www.fda.gov). FDA published a draft guidance on the subject June 28 ("The Tan Sheet" July 5, p. 18). The guidance provides recommendations to NDA and ANDA holders who intend to make post-approval changes in accordance with section 506A of the FDA Modernization Act, which rewrites FDA's Sec. 314.70 manufacturing regs. Categories addressed in the guidance include: "components and composition, manufacturing sites, manufacturing process, specifications, package [and] labeling." In response to comments on the draft, FDA changed certain language in the guidance regarding examples of an annual report change; language pertaining to "sterility assurance" was kept the same, however. For further information, contact CDER's Nancy Sager at (301) 594-5633

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