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DEA proposes revised rules for identifying and reporting suspicious orders of controlled substances

Last week, the U.S. Drug Enforcement Administration (DEA) released its long-awaited proposed rule on Suspicious Orders Monitoring System (SOMS) obligations under the federal Controlled Substances Act. ...more

DEA issues interim final rule implementing 2018 Farm Bill

In the prepublication version of today’s Federal Register, the U.S. Drug Enforcement Agency (DEA) issued an interim final rule (IFR) implementing conforming changes to DEA’s regulations as a result of the Agricultural...more

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Agency seeks input on “comparative advantage” requirement for new opioids - Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...more

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