- What is Prescription Drug Labeling?
- How is Prescription Drug Labeling Approved?
- How is Product Labeling Updated?
What is Prescription Drug Labeling?
Prescription drug labeling [e.g., U.S. Prescribing Information (USPI)] contains a summary of the essential scientific information needed for the safe and effective use of the drug. The USPI provides healthcare providers who use oncology prescription drugs unbiased information regarding the use of the drug, including the setting in which the drug has been shown to be safe and effective, recommended dose and schedule, recommended modifications for toxicity, in patients with renal or hepatic impairment, or based on drug interactions, as well as a summary of potential side effects including severity and frequency.
Additionally, when approved, the USPI is an unbiased source of summary information submitted by the drug manufacturer and then comprehensively reviewed at the FDA for clinical studies conducted to establish the safety and effectiveness of the drug. While many different sources of drug information exist, the USPI provides strong assurances of scientific accuracy.
How is Prescription Drug Labeling Approved?
The oncology product labeling review process is a data-driven, collaborative process conducted by multidisciplinary FDA teams.
Company Submits Draft USPI
A drug company submits a marketing application containing the data supporting the safety and effectiveness of their oncology drug based on one or more clinical studies. The marketing application may be a New Drug Application (NDA), Biologic License Application (BLA), or a supplement to one of these applications. The application must include their proposed USPI.
FDA Forms Application Review Team
An FDA review team typically includes physicians, pharmacologists, toxicologists, statisticians, pharmacists, chemists/biologists, safety specialists, and regulatory scientists.
Consultative reviewers are assigned to evaluate for promotional content and the potential for medication errors in the USPI and to review patient labeling. Additional consultative reviewers with specific subject matter expertise are often added to the review team based on the oncology drug’s proposed conditions of use (e.g., pediatricians, patient reported outcome specialists, epidemiologists, maternal health specialists, pharmacogenomic specialists, and/or other specialists). Furthermore, if the prescription oncology drug must be used with a device (i.e, in vitro diagnostic device, autoinjector), engineers evaluate these devices.
FDA Review of Submission
The FDA review team evaluates the data submitted by the company to determine their adequacy to support approval or new claims and may ask the company for additional data or to clarify certain findings.
If data are adequate, the USPI undergoes a comprehensive review to ensure that the USPI is scientifically accurate, concise and clear, meets regulatory/statutory requirements, and is consistent with FDA guidances for USPI and patient labeling content and format.
Final Approved USPI
The final approved USPI is developed in agreement between the FDA and the company.
How is Product Labeling Updated?
Maintaining FDA-approved USPI occurs throughout the drug’s lifecycle. After initial approval, companies are required to update their USPI when new information becomes available that causes the USPI to be inaccurate, false, or misleading. Additionally, FDA may ask the company to update their labeling by issuing a supplement request letter. This action is most often taken based on identification of new postmarketing safety signals identified by FDA surveillance to conform to new labeling requirements/guidance; or identification of new scientific evidence related to the drug class that is important to the safe and effective use of the drug.
- Project Renewal Home
- Project Renewal FAQ
- About Product Labeling
- FDA Oncology Center of Excellence Home
- Prescription Drug Labeling Resources