To assist healthcare providers and others in the industry during the Coronavirus (COVID-19) pandemic, the US Drug Enforcement Agency (DEA) has issued guidance addressing specific areas of concern, including practitioner...more
On November 7, 2016, the US Court of Appeals for the Ninth Circuit heard arguments in Oregon Prescription Drug Monitoring Program v. United States DEA, No. 14-35402 (9th Cir. 2016). Here, the Drug Enforcement Administration...more
Required Black Box Warnings on Immediate Release Opioids -
Closely following on recent efforts undertaken by states and the Centers for Disease Control to curb opioid abuse (review further here and here), the U.S. Food...more
In response to a significant increase in opioid overdose deaths, the U.S. Centers for Disease Control and Prevention (CDC) released new guidelines [today] regarding prescriptions for opioid painkillers.
The CDC notes...more
On March 14, 2016, Massachusetts Governor Charlie Baker signed comprehensive legislation designed to curb opioid addiction. The legislation reflects growing concern for the “dangers in the medicine cabinet” (i.e., risks...more
On July 13, 2015, the Centers for Medicare & Medicaid (CMS) issued a long-awaited proposed rule (Proposed Rule) that would revise the requirements that long-term care (LTC) facilities must meet to participate in the Medicare...more
7/16/2015
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Training Requirements
On June 30, 2015, the U.S. Food and Drug Administration (FDA) announced its intention to exercise its enforcement discretion to delay until November 1, 2015, its enforcement of drug product “track and trace” requirements...more