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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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.
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.
From surprisingly contentious to surprisingly unanimous, VRBPAC's favorable votes have grown from 17 to 21 over the course of three meetings on coronavirus vaccines.