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# PD-1/PD-L1 Alternative Dosing Regimen Draft Guidance
- URL: https://www.fdaweb.com/pd-1-pd-l1-alternative-dosing-regimen-draft-guidance/
- Published: 2021-08-25T12:00:00.000Z
- Updated: 2026-09-14T17:11:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150010

FDA has published a draft guidance, *Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death Receptor-Ligand 1 (PD-L1) Blocking Antibodies*, with recommendations for sponsors of INDs and BLAs. The [document](mailto:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pharmacokinetic-based-criteria-supporting-alternative-dosing-regimens-programmed-cell-death-receptor) says it is based on accumulated scientific and regulatory experience for PD-1 and PD-L1 drugs and does not address the development of alternative dosing regimens for other drugs or biologics, changes in the route of administration, or novel formulations of previously-approved PD-1/PD-L1 products.

The draft covers Introduction and Background, PK-Based Approach, and Regulatory Interaction and Submission.