This Cooperative Agreement award from the Food and Drug Administration (FDA) under the FDA Research program (CFDA 93.103) provides $298,422 to Brigham & Women's Hospital Inc. to develop a semi-automated surveillance system for monitoring the safety and effectiveness of generic drug-device combinations compared to branded products. The project aims to generate real-world evidence on utilization patterns, comparative effects, and potential safety signals for these complex medications using healthcare databases. The research will build on pharmacoepidemiological methods to describe patient characteristics, evaluate pre-specified outcomes, and screen for unsuspected safety issues. The goal is to create a reusable framework and tools that the FDA can employ when using real-world evidence to evaluate generic drug-device combinations in the post-marketing setting. This 3-year award, starting on Sep 1, 2024, will leverage the expertise of Brigham & Women's Hospital, which is a subsidiary of the larger Partners Healthcare System.
Mod # | Description | Reason For Modification | Federal Obligation (Click to sort descending) | Date (Click to sort ascending) |
|---|---|---|---|---|
| Not listed | $298.4k | 8/27/24 |