On June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adults with locally advanced or metastatic […]

Image The OCE supports clinical projects to improve oncology product development for the benefit of people with cancer.  Jump to: Patient-Focused Drug Development Program The OCE […]

AUDIENCE: Patient, Health Care Professional, Neurology ISSUE: The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause […]

On June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma […]

Through August 16, 2024, FDA identified 13 cases worldwide, including 7 in the United States, of hyperthermia associated with scopolamine patches from the FDA Adverse Event […]

On This Page Date: July 18, 2025 Time: 9:00 a.m. – 4:00 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to […]

Below are CDER’s COA Qualification Program’s frequently asked questions (FAQs). We also recommend reviewing the general COA FAQ web page. General CDER COA Qualification Program Information […]

The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of the 21st Century Cures Act), as […]

How to engage with the Biomarker Qualification Program (BQP) If you have pre-submission or general inquiry questions or you want to make a meeting request, please […]