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.
SAN DIEGO – After years of rare disease community lobbying, the US Food and Drug Administration has decided to create a rare disease center of excellence, but will not give it that title.
The rare disease hub will allow experts in CDER and CBER to collaborate and offer a single point of contact for sponsors.
A rare disease “hub” that would facilitate collaboration between the Center for Drug Evaluation and Research and the Center for...
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.
