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CDER has released a guidance for industry highlighting deficiencies in impurity information that may cause the agency to refuse to receive (RTR) an ANDA for a new strength of the drug product. The guidance explains that FDA may RTR an ANDA for not justifying specified identified and unidentified impurities that are above ID thresholds, and proposing limits for unspecified impurities above ID thresholds.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
