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In Brief: FDA proposed CGMP amendments

This article was originally published in The Tan Sheet

Executive Summary

FDA proposed CGMP amendments: FDA indicates that it will extend the comment period for proposed amendments to the CGMP regulations for pharmaceuticals by 60 or 90 days in response to requests from industry. PhRMA and Perrigo asked the agency for additional time to comment on the proposal, published in the May 3 Federal Register, which would clarify certain manufacturing, quality control and documentation requirements, ensure that the regs more accurately encompass CGMP and update the process and methods validation requirements to incorporate previously issued guidance and current practice. The current deadline for written comments is Aug. 1...
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