FDA releases updated guidances for injectable peptide drugs and announces FY 2027 user fee rates
The FDA has updated 17 draft product-specific guidances aimed at helping sponsors prepare abbreviated new drug applications for injectable peptide products.
The guidances cover peptide therapies used in areas such as obesity, type 2 diabetes, osteoporosis, and macular degeneration, providing detailed expectations for formulation, manufacturing, and clinical data.
In a separate announcement, the agency released its FY 2027 user fee schedule for prescription, generic, biosimilar, medical device, and OTC drug programs, basing the rates on projected application volumes and resource needs.
The updates are intended to streamline review processes and give industry clearer pathways for bringing peptide-based treatments to market.
This writeup was produced by pharmadog from original reporting by raps.
Original headline: “FDA updates product-specific guidelines for injectable peptides”
read at raps ↗
comments(0)
5-min edit window · permanent after that