Optimizing the Dosageof Human PrescriptionDrugs and BiologicalProducts for theTreatment of OncologicDiseasesGuidance for IndustryDRAFT GUIDANCEThis guidance document is being distributed for comment purposes only.Comments and suggestions regarding this draft document should be submitted within 60 days ofpublication in the Federal Register of the notice announcing the availability of the draftguidance.Submit electronic comments to https://www.regulations.gov.Submit writtencomments to the Dockets Management Staff(HFA-305),Food and Drug Administration,5630Fishers Lane,Rm.1061,Rockville,MD 20852.All comments should be identified with thedocket number listed in the notice ofavailability that publishes in the Federal Register.For questions regarding this draft document,contact Mirat Shah at 301-796-8547 or Stacy Shordat301-796-6261.U.S.Department of Health and Human ServicesFood and Drug AdministrationOncology Center of Excellence (OCE)Center for Drug Evaluation and Research(CDER)Center for Biologics Evaluation and Research (CBER)January 2023Clinical/Medical
