Solicitation Number: FDA-SSN-1227793
“The U.S. Food and Drug Administration (FDA) is issuing this Request for Information (RFI)/Sources Sought notice to identify possible sources with capability to support the FDA Center for Drug Evaluation and Research’s (CDER) upcoming requirement for the Oncology Center of Excellence (OCE) Drug Labelling Initiative.”
- Deploy and iteratively improve the repeatable, scientific-based Labeling Evidence Evaluation Process developed by the initial Project Renewal pilot program
The Contractor shall work with the FDA and organizations such as the American Association of Cancer Research (AACR), American Society of Hematology (ASH), and American Society of Clinical Oncology (ASCO) to identify key stakeholders for review panels, through an open solicitation process.
The Contractor shall establish operations for the development, execution, and documentation of processes throughout the drug labeling evidence evaluation. The Contractor shall use sustained risk management and performance measurement to identify and capture lessons learned for continuous process improvement – to reduce process time, lower cost, and improve quality of project processes and deliverables.
- Automation of Data Collection and Document Development for Use Data and Evidence to Support Labeling Updates
The Contractor shall work with the FDA to develop an overarching process for collecting and annotating data supporting labeling changes including current claims/labels, number of prescriptions written for products, types of clinical data needed to support expanded labels…”