GUIDANCE DOCUMENT
Real-Time Oncology Review (RTOR) Draft Guidance for Industry July 2022
Not for implementation.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This guidance is being distributed for comment purposes only.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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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
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All written comments should be identified with this document's docket number: FDA-2022-D-0823
- Docket Number:
- FDA-2022-D-0823
- Issued by:
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Guidance Issuing OfficeOncology 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.
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