Table of Contents
ACPS November 15, 2000
Regulatory Approach
21 CFR 314.70: Supplements and Other Changes to an Approved Application (1985 rewrite)
PPT Slide
FDA Modernization Act Section 116 (November 1997)
FDAMA Section 116
FDAMA Section 116: Reporting Categories
FDAMA 116 Implementation Status
Changes to an Approved NDA or ANDA (Nov. 1999 guidance)
FDAMA 116 Implementation Status
FDAMA 116 Implementation Status (cont’d)
FDAMA 116 Implementation Status (cont’d)
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Author: CDER USER
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