FDA Funding In Cures Bill Complicated By Metrics, Appropriators
But a Harvard researcher argues to improve drug development, basic research should receive more money because FDA review is not the problem.
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Unsure About ‘Breakthrough’-Worthiness? Talk To FDA First
An early, informal conversation between a sponsor and the review division about the supportive data could help reduce the number of ‘breakthrough therapy’ designation requests that are ultimately denied, FDA and sponsors said.
Congressional ‘Cures’ Debate Shifts To FDA Funding
House Democrats say FDA will need more money to be able to handle the responsibilities in the draft bill, while the agency worries reviews could slow without more resources.
US FDA Formalizes ‘One-Trial’ Approach For Oncology Accelerated Approval
Draft guidance gives recommendations for conducting one randomized controlled trial to generate the evidence for accelerated approval and confirm clinical benefit.