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House Appropriators Will Tell US FDA 'Don't Finalize' LDT Guidance In 2018 Funding Bill

Executive Summary

When the House Appropriations Committee takes up the US FDA funding bill for 2018, report language would "prevent the agency from finalizing a guidance on regulating laboratory developed tests," Rep. Rosa DeLauro said at a June 28 Ag/FDA subcommittee markup. The House bill, while maintaining FDA discretionary funding at its prior-year $2.8bn level, also fully appropriates user fee authorizations agreed to by Senate and House Committees in FDA Reauthorization bills in May and June, respectively.

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