US FDA Wins Big In Shutdown-Averting Approps Bill
Agency 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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Opioid 'Data Warehouse' Is Part Of US FDA's New Controlled Substances Program
CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.
Drug Importation Is A High-Profile Addition To US FDA’s Regulatory Agenda
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.