Rare Diseases: US FDA Gives More Guidance On Premarket Safety Evaluation, Historical Controls
Agency specifies several approaches to augment safety assessment in a new draft guidance, which also encourages participation by patients and their advocates in the drug development process.
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Stealth Elamipretide NDA Tests Frontiers Of US FDA’s Flexibility In Rare Diseases
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Nearly 9% FY 2019 Increase For FDA In Shutdown-Averting Appropriations Bill
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.
US FDA Wins Big In Shutdown-Averting Approps Bill
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