US FDA Wins Big In Shutdown-Averting Approps Bill
Executive SummaryAgency would receive more than $268m in additional dollars for medical product and food safety as part of substantial FY 2019 increase.
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CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.
Agency is targeting January 2020 for release of controversial proposed rule to allow importation of certain types of prescription drugs from Canada; although most Rx drug-related proposed and final rules on the Fall 2019 regulatory agenda are making repeat appearances, a final rule on electronic distribution of prescribing information has fallen off the list.
Database is expected standardize natural history and other data collection, but won't help streamline drug development in the space for a while yet.