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    FDA guidance spells out acceptance criteria for synthetic peptide ANDAs

    The US Food and Drug Administration (FDA) issued a final guidance on its criteria for accepting abbreviated new drug applications for synthetic peptide drugs of recombinant DNA (rDNA) origin.   The guidance is meant to spur the development of these complex drugs.  The agency also rejected industry calls to eliminate the impurity limit thresholds for accepting these submissions as abbreviated new drug applications (ANDAs).   The guidance, which finalizes 2017 draft ...