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# Draft Guide on PD-1, PD-L1 Alternative Dosing
- URL: https://www.fdaweb.com/draft-guide-on-pd-1-pd-l1-alternative-dosing/
- Published: 2021-08-26T12:00:00.000Z
- Updated: 2026-09-14T17:12:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150020

*Federal Register* notice: FDA has made available a draft guidance entitled *Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD–1) or Programmed Cell Death-Ligand 1 (PD–L1) Blocking Antibodies for Treatment of Patients with Cancer*. The document provides recommendations on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for such therapies. It is based on accumulated scientific and regulatory experience for PD–1 and PD–L1 drugs. The guidance does not address development of alternative dosing regimens for any other drugs or biologics, changes in route of administration, or novel formulations of previously approved PD–1/PD–L1 products. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-08-26/pdf/2021-18317.pdf?ref=fdaweb.com).