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Guidance Documents/Guidance-Document/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: Guidance for Industry

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: Guidance for Industry

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

December 6, 2022

December 6, 2022

Office of the Commissioner

39b5200a-95fe-45d2-ac1a-170502282ac4

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