USA – Guidance : Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes

This guidance is intended to inform new drug application (NDA) and abbreviated new drug application (ANDA) holders of the Food and Drug Administration’s (FDA’s) plan to use enforcement discretion with regard to section 314.70(c)(2)(iii) of the final rule entitled Supplements and Other Changes to an Approved Application (21 CFR 314.70(c)(2)(iii)). This subsection describes the filing requirement that a relaxation of acceptance criteria or deletion of a test to comply with an official compendium must be reported in a changes-being-effected-in-30- days supplement (CBE-30). In the exercise of its enforcement discretion, FDA does not intend to take enforcement action if manufacturers continue to submit such changes in their annual reports. The use of enforcement discretion will give the Agency time to clarify that some of these types of postapproval changes can be submitted in an annual report, rather than in a CBE-30. The Agency intends to clarify this issue in an upcoming revision to the guidance for industry Changes to an Approved NDA or ANDA; Questions and Answers…