House Appropriators Warn US FDA: Stop Working On Electronic Labeling Rule
Congress is 'very concerned' about potential final rule that would move to electronic labeling in lieu of paper distribution with prescriptions.
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Consolidated Appropriations Act gives FDA $5.58bn overall, 8.7% more than allocated in FY 2018. FDA received $268.8m in additional budget authority and $178.3m in additional user fee funds. FY 2019 funding would have lapsed Feb. 16 and another government shutdown would have started if President Trump didn't sign the bill on Feb. 15.
Agency would receive more than $268m in additional dollars for medical product and food safety as part of substantial FY 2019 increase.
With cell and gene therapies becoming more popular, CBER Director Marks says in an interview with the Pink Sheet that more staff may be needed soon.