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Drug Master File (DMF) Holders Preferred PGI Control Strategy Under ICH M7 in Support of Abbreviated New Drug Applications (ANDAs)

pdf fileScott B; Green D; Hu X; Wang J; Skanchy D;

Presented by the US Food and Drug Administration.

FDA Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of New Drug Products, Division of Lifecycle Active Pharmaceutical Ingredients
CDER/OPQ/ONDP/DLAPI

 

ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk is now fully implemented and makes available a variety of approaches to control potentially genotoxic impurities (PGIs) based on the maximum daily dose, duration of use, and indication of the drug product. The limit to which a PGI is controlled, based on these factors is defined as the threshold of toxicological concern or TTC.  

Once the need for control of a PGI is identified and the standardized deficiency from DLAPI is issued, a firm can use any of the following approaches as a control strategy in their response: 

1) Use Options 1-4 provided in ICH M7
2) Provide negative (Q)SAR data
3) Provide a complete AMES study

This poster provides a survey of the choices DMF holders have submitted to the Agency to control PGIs based on ICH M7. 

 

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