New Draft Guidance for Industry - Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Hematologic Malignancy and Oncologic Disease:  Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development.”  This draft guidance provides recommendations to industry regarding the use of placebos and blinding in randomized controlled clinical trials in development programs for drug or biological products for the treatment of hematologic malignancies and oncologic diseases regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).