CDER lists guidances in the works for 2009
This article was originally published in The Gold Sheet
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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