Real-Time Oncology Review (RTOR) Guidance for Industry November 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-2022-D-0823
• Issued by: 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 (NDAs) and biologics license applications (BLAs) with oncology indications for review under 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 (May 2014). RTOR is separate from the Split Time Application Review (STAR) pilot program which was established under the Prescription Drug User Fee Act (PDUFA) VII commitments.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

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