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FDA calls for input on peptide evaluation

Posted 13 May 2021 | By Kari Oakes 

FDA calls for input on peptide evaluation

The US Food and Drug Administration (FDA) is seeking comments on strategies for the pharmacological assessment of peptides, small polymers made up of 40 or fewer amino acids.
 
“For the purpose of this request, FDA is specifically interested in comments regarding the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of peptides, as well as the effects of peptides on cardiac electrophysiology,” wrote FDA in announcing its call for feedback in a 13 May Federal Register notice.
 
However, wrote the agency, the development of peptides may involve other considerations, so FDA is seeking commentary in all relevant areas.
 
The request applies to peptides isolated from animal tissue as well as that produced  in vitro through synthesis or a recombinant genetic process. Though the notice observes that “FDA has been regulating peptides for decades,” the agency has no guidance that specifically addresses considerations in clinical pharmacology recommendations for peptide development.
 
FDA is seeking input on when certain assessments are or are not warranted. These include looking at pharmacokinetics-based drug-drug interactions, pharmacokinetics in hepatic impairment, immunogenicity and its downstream effects and the potential for prolongation of the QT segment.
 
If the commenter deems that an assessment is warranted, then FDA asks for an explanation of which assessments are warranted, and why they should be employed. Study design characterizations should also be enumerated, and a rationale provided. For all approaches, FDA asks that the comments included advantages, challenges and limitations.
 
If a comment addresses considerations not enumerated by FDA in its request, the response should also provide a description and rationale for the proposed consideration. FDA envisions that there may be pharmacodynamic biomarkers or pharmacokinetic assessments that would be useful in assessing peptides during their development.
 
"The public comments collected will help FDA develop recommendations for the design and conduct of clinical pharmacology studies important to the understanding of the safe and effective use of peptides and facilitate the regulatory assessment of such studie," wrote the agency.
 
FDA is requesting that commentary be submitted by 60 days after the publication of the notice.
 
FR Notice

 

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