Manufacturing Changes To Comply With USP Standards Require Supplements In Certain Cases, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA final manufacturing rule states that changes made to comply with USP standards that relax acceptance criteria or delete tests would require changes-being-effected supplement. Other USP compliance changes would only require annual reports.
You may also be interested in...
FDA To Use Enforcement Discretion Regarding Changes To NDAs, ANDAs
Post-approval manufacturing changes made to comply with U.S. Pharmacopeia standards may be submitted in an annual report, an FDA guidance states. The agency plans to clarify the types of changes that can be submitted in an annual report instead of a supplemental filing in an upcoming guidance.
FDA To Use Enforcement Discretion Regarding Changes To NDAs, ANDAs
Post-approval manufacturing changes made to comply with U.S. Pharmacopeia standards may be submitted in an annual report, an FDA guidance states. The agency plans to clarify the types of changes that can be submitted in an annual report instead of a supplemental filing in an upcoming guidance.
Manufacturing Final Rule Allows Changes Related To USP Standards To Skip Preliminary Notification
Such changes could be included in annual reports unless they result in relaxation of accepted criterion or deletion of tests, in which case they must be approved before enactment. FDA's final rule mostly follows a 1999 proposal to reduce the number of manufacturing changes that require agency notification.