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  1. Oncology Center of Excellence

Oncology Center of Excellence Guidance Documents

Listed below are recently added guidance documents regarding oncology and malignant hematology.

 Title  Type  Date Posted
Male Breast Cancer: Developing Drugs for Treatment  Draft  08/26/2019
Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations  Final  05/09/2019
Cancer Clinical Trial Eligibility Criteria: Brain Metastases  Draft  03/13/2019
Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients  Draft  03/13/2019
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections  Draft  03/13/2019
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials  Draft  03/13/2019
Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products  Draft  12/07/2018
Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials (PDF - 72KB)  Draft  11/13/2018
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry  Draft  10/15/2018
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry  Draft  09/28/2018
Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development Guidance for Industry  Draft  08/23/2018
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry  Draft  08/10/2018
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry  Draft  06/28/2018
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials  Draft  06/01/2018
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry  Draft  04/12/2018
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry  Draft  02/12/2018
Commenting on Guidance Documents

Some FDA guidance documents on this list are indicated as open for comment. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on a draft guidance that is open for comments before it begins work on the final version of the guidance, submit either electronic or written comments by the closing date. Comments are submitted electronically through regulations.gov. For more information, see:

About FDA Guidances

Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office. Another method of obtaining guidance documents is through the Division of Drug Information.

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