Meeting requests related to the Oncology Center of Excellence’s new dose optimization approach are increasing, along with sponsor questions, prompting the US FDA to determine how to clarify its intentions.
SAN DIEGO – US Food and Drug Administration officials are finding that demanding dose-finding studies earlier in development is not as easy as it may appear in a policy document.
OCE’s Angelo De Claro said sponsors are unclear about many aspects of the center’s dose optimization program.
Angelo De Claro, associate director for global clinical sciences in the FDA Oncology Center of Excellence, said sponsors continue to...
Many platform designation requests have been from sponsors eager to cite other sponsors’ products, but CBER Director Peter Marks said in an interview with the Pink Sheet his office likely is years away from accepting those applications.
Meeting requests related to the Oncology Center of Excellence’s new dose optimization approach are increasing, along with sponsor questions, prompting the US FDA to determine how to clarify its intentions.
The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.
While not brandishing the name advocates have pushed for many years, the rare disease hub will play much the same role as a center of excellence in increasing collaboration between experts in the FDA drug and biologics centers.
While not brandishing the name advocates have pushed for many years, the rare disease hub will play much the same role as a center of excellence in increasing collaboration between experts in the FDA drug and biologics centers.
With the much-anticipated guidance still pending, OCE’s Tamy Kim reminds industry of the requirements and timing around avoiding the soon-to-be requirements on study enrollments.
The FDA does not appear likely to provide a calculation for sponsors to show clinical trial diversity, but agency officials seem split on how tough to enforce the new regulations intended to ensure all groups are adequately represented.
