Real-time oncology review (RTOR): guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Oncology Center of Excellence (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, November 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products Drug Approval Drug Industry Drugs, Investigational Government Regulation Neoplasms -- drug therapy United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- 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. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (6 pages))
- NLM Unique ID:
- 9918733086806676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918733086806676