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The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.
On August 24, 2016, FDA published guidance regarding the preparation and submission of original abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs seeking approval of a new strength of the drug product. The agency addresses deficiencies in information provided by applicants about impurities, which would cause FDA to refuse to receive (RTR) an ANDA.
FDA may make an RTR decision if the agency feels the ANDA is not complete enough to review. The guidance states that deficiencies may include “failing to provide justification for proposed limits in drug substances and drug products for specified identified impurities that are above qualification thresholds; failing to provide justification for proposed limits for specified unidentified impurities that are above identification thresholds; and proposing limits for unspecified impurities (e.g., any unknown impurity) that are above identification thresholds.”
In the guidance, FDA clarifies how a failure to provide justification for proposed impurity limits may result in an ANDA being refused. The guidance offers recommendations for including the appropriate justification for impurities in ANDA submissions.