Home » FDA Adopts ICH Stability Testing Guidelines for ANDAs
FDA Adopts ICH Stability Testing Guidelines for ANDAs
The FDA has adopted international recommendations for ANDA stability testing, brushing aside complaints from generic drugmakers that the guidelines are heavy-handed. In a two-page final guidance released, the agency calls for ANDA submissions to follow International Conference on Harmonisation (ICH) stability recommendations for drug products and substances.
Washington Drug Letter
Washington Drug Letter
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