USA – FDA issues draft guidance of clinical pharmacology, labeling considerations for peptide drug products

The US Food and Drug Administration (FDA) has released a draft guidance outlining the agency’s clinical pharmacology and labeling considerations for peptide drug products.

When finalized, the guidance will represent the agency’s thinking on development programs for new drug application (NDA) peptide drug products. “The intent of this draft guidance, when finalized, is to assist industry in the conduct of these development programs,” FDA wrote on the agency’s webpage for the draft guidance.

The draft guidance follows the publication last year of a set of concept papers from the European Medicines Agency (EMA) proposing quality guidelines for manufacturing synthetic peptides and oligonucleotides (RELATED: EMA proposes quality guidelines for synthetic peptides and oligonucleotidesRegulatory Focus 22 September 2022)…