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CDER lists guidances in the works for 2009

This article was originally published in The Gold Sheet

Executive Summary

FDA's Center for Drug Evaluation and Research has listed several drug quality-related documents on its guidance agenda for 2009, including ones in the chemistry category for: CMC postmarketing plans, annually reportable CMC post-approval changes, assay development for immunogenicity testing, immunogenicity assessment for therapeutic protein products, incorporation of physical-chemical identifiers into solid oral dosage forms for anti-counterfeiting, and standards recognition. In the compliance category, CDER is developing guidances on contract manufacturing, dosage delivery devices for OTC liquids, non-penicillin beta-lactam contamination, Part 11 electronic records, positron emission tomography cGMPs, pharmaceutical component quality control, pharmaceutical components at risk for melamine contamination, pharmaceutical manufacturing statistics, pre-launch activities importation request, and process validation general principles and practices

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