Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Oncology Center of Excellence

Oncology Center of Excellence

                        Who We Are - Oncology Center of Excellence
          Project Patient Voice


                        OCE Annual Reports
          Project Community Home
          About FDA
          FDA Organization
          Oncology Center of Excellence
          Oncology Center of Excellence Guidance DocumentsOncology Center of Excellence Oncology Center of Excellence Guidance Documents
  
  	
    Share
    Post
    Linkedin

    Email
    PrintListed below are recently added guidance documents regarding oncology and hematologic malignancies.

Title
			Type
			Date PostedReal-Time Oncology Review (RTOR)
			Final
			November 2023Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products
			Draft
			August 2023QTc Information in Human Prescription Drug and Biological Product Labeling
			Draft
			August 2023Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program
			Final
			June 2023Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics
			Draft
			March 2023Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases
			Draft
			January 2023Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer
			Final
			December 2022Cross Labeling Oncology Drugs in Combination Regimens
			Final
			November 2022Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment
			Final
			October 2022Tissue Agnostic Drug Development in Oncology
			Draft
			October 2022Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials
			Draft
			October 2022Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings
			Final
			July 2022Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment
			Final
			June 2022Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment
			Final
			June 2022Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues
			Final
			May 2022Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development
			Draft
			May 2022Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials
			Draft
			April 2022Inclusion of Older Adults in Cancer Clinical Trials
			Final
			March 2022Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics
			Final
			March 2022Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology
			Final
			March 2022Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials
			Final
			August 2021Evaluating Cancer Drugs in Patients with Central Nervous System Metastases
			Final
			July 2021Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
			Final
			June 2021Core Patient-Reported Outcomes in Cancer Clinical Trials
			Draft
			June 2021Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention
			Draft
			May 2021COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention
			Final
			May 2021FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act
			Final
			May 2021Geriatric Information in Human Prescription Drug and Biological Product Labeling
			Draft
			September 2020Male Breast Cancer: Developing Drugs for Treatment
			Final
			August 2020Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans
			Final
			July 2020Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval
			Final
			July 2020Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products
			Draft
			July 2020Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections
			Final
			July 2020Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies
			Final
			July 2020Cancer Clinical Trial Eligibility Criteria: Brain Metastases
			Final
			July 2020Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients
			Final
			July 2020Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products
			Final
			April 2020Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment
			Final
			January 2020Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination
			Final
			October 2019Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products
			Final
			August 2019Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations
			Final
			August 2019Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations
			Final
			May 2019Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
			Final
			March 2019Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
			Final
			December 2018S9 Nonclinical Evaluation for Anticancer Pharmaceuticals—Questions and Answers
			Final
			June 2018Bacillus 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:

How to Use Regulations.gov
	Find and Comment on FDA DocketsAbout 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.

Search all FDA Guidances

                                                                                  Content current as of:
      11/08/2023Oncology Center of Excellence

          
                        Who We Are - Oncology Center of Excellence
          Project Patient Voice


                        OCE Annual Reports
          Project Community
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop