NO NEW GMP, ICH DRAFT GUIDANCES EXPECTED IN 2004

Drug GMP Report
KEYWORDS Guidances
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The FDA said it plans to finalize its cGMP guidances on process analytical technologies (PATs), aseptic processing, comparability protocols (CPs), and formal dispute resolution later this year, but no new draft guidances on GMP and International Conference on Harmonisation (ICH) initiatives will be issued.

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