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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
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment Draft October 2020
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment Draft October 2020
Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment Draft October 2020
Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry Draft September 2020
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases Draft August 2020
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment Draft August 2020
Male Breast Cancer: Developing Drugs for Treatment Final August 2020
Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans Final July 2020
Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval Final July 2020
Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products Draft July 2020
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 Final 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
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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