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New Guidance on Reporting Procedures for NDA and ANDA Post-Approval Changes

Changes that are made to an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) are referred to as "post-approval" changes. All post-approval changes must be filed with the U.S. Food and Drug Administration (FDA) and are classified as major, moderate, or minor. The type of classification determines the type of documentation FDA requires for each notification. Major and moderate changes require supplemental filings and, depending on the severity of the change, may require FDA approval prior to market distribution. Minor changes, on the other hand, can be submitted via annual reports and do not require FDA clearance before the new product is distributed. (See the article, Degree of Post-Approval Changes to Drug Packaging Impacts Reporting Requirements, for more details.)

In an effort to streamline its regulatory review process, FDA conducted an evaluation of the type of chemistry, manufacturing, and controls (CMC) post-approval manufacturing notifications it received and determined that many of the changes represented low risk and did not need to be filed in supplements. As a result, FDA released Guidance for Industry: CMC Postapproval Manufacturing Changes to be Documented in Annual Reports in March 2014 The Guidance details manufacturing changes (see Appendix A) and Scale-up and Postapproval Changes (see Appendix B) that may be classified as minor, and, therefore, only need to be reported in a DMF's Annual Report. NDA or ANDA holders may still submit a supplemental filing for the changes listed if they determine that the changes are unique and warrant a supplemental filing. However, except in unique cases, supplemental filings are no longer needed for changes listed in Appendix A and Appendix B of FDA's Guidance for Industry.