ACPS November 15, 2000

12/20/00


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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)

Author: CDER USER