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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Clinical Pharmacology Considerations for Peptide Drug Products.” This guidance describes FDA’s recommendations regarding clinical pharmacology considerations for peptide drug product development programs, including hepatic impairment, drug-drug interactions (DDIs), assessing QTc prolongation risk, and immunogenicity risk and impact on the pharmacokinetics (PK), safety, and efficacy assessment. The intent of this draft guidance, when finalized, is to assist industry in the conduct of these development programs.