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Oncology Center of Excellence Guidance Documents

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

 Title  Type  Date Posted
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections  Final  July 2020
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies  Final  July 2020
Cancer Clinical Trial Eligibility Criteria: Brain Metastases  Final  July 2020
Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients  Final  July 2020
Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products  Final  April 2020
Inclusion of Older Adults in Cancer Clinical Trials  Draft  March 2020
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry  Final  January 2020
Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers  Draft  January 2020
FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act  Draft  December 2019
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination  Final  October 2019
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products  Final  August 2019
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations  Final  August 2019
Male Breast Cancer: Developing Drugs for Treatment  Draft  August 2019
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues  Draft  July 2019
Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations  Final  May 2019
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials  Final  March 2019
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics  Final  December 2018
Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials  Draft  November 2018
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology  Draft  September 2018
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry  Draft  August 2018
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals—Questions and Answers  Final  June 2018
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment  Final  February 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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