Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12,12″][membership]
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 – an overall increase of 11% compared to the FY 2018. The request includes: ● $3.2 billion for budget authority – an increase of 14% or $432.9 million, and ● $2.5 billion for user fee – 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: ● efforts to advance a new paradigm in the regulation of digital health technology ● investments in advanced manufacturing ● support for compounding pharmacies to expand their businesses programs to modernize generic drug review ● approaches to support the development of treatments for rare pediatric diseases, and ● efforts to build a knowledge management platform in drug and medical device review programs.
[/membership]