U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Real-Time Oncology Review (RTOR)
  1. Search for FDA Guidance Documents


Real-Time Oncology Review (RTOR) Draft Guidance for Industry July 2022


Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0823

Docket Number:
Issued by:
Guidance Issuing Office
Oncology Center of Excellence

The purpose of this guidance is to provide recommendations to applicants on the process for submission of selected New Drug Applications (NDA) and Biologic License Applications (BLA) with oncology indications for review under the Real-Time Oncology Review (RTOR).

This guidance does not address FDA’s expedited programs such as the Fast Track Designation, Breakthrough Therapy Designation, or Priority Review Designation. Additional information on these expedited programs can be found in the Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics.


Contact Point
Human Drug Information
Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993
(855) 543-3784 Toll Free
(301) 796-3400
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
(800) 835-4709
(240) 402-8010
Back to Top