FDA releases FY 2027 user fee rates and updates guidance for injectable peptide ANDAs

The U.S. Food and Drug Administration has published its user fee rates for fiscal year 2027, covering prescription drugs, generics, biosimilars, medical devices and over‑the‑counter products. The rates are based on the agency’s resource needs and the volume of applications it anticipates, using historical trends as a guide.

In addition, the FDA issued updates to 17 draft product‑specific guidances aimed at sponsors preparing abbreviated new drug applications for injectable peptide products. These guidances are intended to clarify expectations and streamline the review process.

The new guidances focus on peptide therapies used to treat obesity, type 2 diabetes, osteoporosis and macular degeneration, providing detailed recommendations for developers of these treatments.