FDA labeling format PLR format oncology drugs FDA

FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs

by Paul G. Kluetz, Patricia Keegan, George D. Demetri, Katherine Thornton, Joohee Sul, Janice Kim, Harvey Katzen, Laurie Beth Burke, R. Donald Harvey, Elleni Alebachew, Sundeep Agrawal, Abhilasha Nair, Martha Donoghue

Feb 15^th 2021
13 mins
Clin Cancer Res (2021) 27 (4): 916–921

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Summary

The FDA conducts independent reviews of scientific data to ensure the safety and efficacy of investigational drug products.
FDA-approved product labeling is a highly trusted source of information for approved drug use.
FDA approval is only the beginning of a drug's lifecycle, with ongoing clinical experiences spanning decades.
Some companies may not update FDA-approved labeling with new data, other than safety information, due to lack of incentives.
Ensuring adequate directions for use in product labeling is crucial for all drugs, particularly older therapies used in standard combination regimens.
Project Renewal is an FDA Oncology Center of Excellence pilot program designed to review literature and update FDA-approved product labeling.
The program collaborates with the clinical and scientific oncology communities to generate reports that support labeling updates.
The article discusses Project Renewal's process for identifying and assessing literature, and its effort to engage the oncology community.

The FDA-approved product labeling is a summary of information verified during FDA's independent, unbiased review of pharmaceutical quality, nonclinical and clinical pharmacology, and clinical study data. In 2006, the Physician Labeling Rule (PLR) was published, creating a consistent content and format for product labeling, including highlights of prescribing information, a table of contents, and 17 discrete sections intended to improve healthcare providers' ability to locate important prescribing information (Table 1). The most updated version of FDA product labeling for each approved product is available to the public online....

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FDA labeling format, PLR format, oncology drugs, FDA