The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.'' The purpose of this draft guidance is to provide advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical development of cancer drugs, including biological products, through multiple expansion cohort study designs.
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Expansion Cohorts: Use in First-In-Human Clinical Trials To Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Expansion Cohorts: Use in First-In-Human Clinical Tri...
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83 FR 40055
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“Expansion Cohorts: Use in First-In-Human Clinical Trials To Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry; Availability,” thefederalregister.org (August 13, 2018), https://thefederalregister.org/documents/2018-17273/expansion-cohorts-use-in-first-in-human-clinical-trials-to-expedite-development-of-oncology-drugs-and-biologics-draft-gu.