US FDA Budget Boost Would Increase Domestic Drug Manufacturing By Better Regulating New Technologies
FDA’s fiscal year 2020 budget request calls for spending on figuring out how to regulate new drug manufacturing technologies under the rubric of increasing US domestic manufacturing.
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Proposal, which would increase capacity for pandemic supplies, is similar to ideas President Trump embraced pre-pandemic.
CBER Director Peter Marks said the agency could streamline development by allowing sponsors to depend on an already-approved manufacturing platform and reviewing any modifications that are proposed.
Overall percentage increase is not as high as the FY 2019 spending bill, but stakeholders are happy with the proposed boost in budget authority.