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FDA's MANUFACTURING CHANGE POLICIES

This article was originally published in The Gold Sheet

Executive Summary

...continue to be examined for opportunities to further down-regulate. Industry and FDA met at a widely-attended public workshop recently to review their experience with the agency's 1999 guidance on NDA/ANDA changes and to discuss potential revisions that might help in the CMC streamlining effort. Industry participants urged the agency to continue to focus on SUPAC as another important component in this effort. [Recommendations on improving the "changes" guidance made by participants during the breakout sessions at the workshop are provided. The sessions covered -- sterile drug substances/products -- tests and acceptance criteria -- components and composition -- manufacturing site -- manufacturing process -- labeling, and -- miscellaneous.]
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