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FDA published budget documentation for FY 2019 and five-year user fee financial plans for BSUFA II, GDUFA II, and PDUFA VI. The FY 2019 budget request is $5.8 billion β an overall increase of 11% compared to the FY 2018. The request includes: β $3.2 billion for budget authority β an increase of 14% or $432.9 million, and β $2.5 billion for user fee β an increase of 7% or $189.9 million compared to the FY 2018. In remarks on the FY 2019 budget proposal, FDA Commissioner Gottlieb noted that it includes: βΒ efforts to advance a new paradigm in the regulation of digital health technology β investments in advanced manufacturing β support for compounding pharmacies to expand their businesses programs to modernize generic drug review β approaches to support the development of treatments for rare pediatric diseases, and β efforts to build a knowledge management platform in drug and medical device review programs.
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