Each year, FDA prepares annual reports on the science and research-funded projects conducted under the Generic Drug User Fee Amendments of 2017 (GDUFA II) regulatory science program. These reports provide greater transparency regarding the important w...
FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma
For Immediate Release Septemb...
Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), provides a framework for concurrent submission and review of oncology products among international partners.
Collaboration among international regulators may allow patients wi...
Scientists at the U.S. Food and Drug Administration (FDA) have developed a mathematical tool that predicts whether the body will produce antibodies that block the activity of biotherapeutic protein drugs.
The computational tool, called TCPro, simula...
