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Clinical trials for depot buprenorphine products for opioid dependence treatment should not focus on standard endpoints, but also consider novel efficacy endpoints not directly focused on opioid use, according to new guidance released by the FDA. Read More
The federal government issued a notice of proposed rulemaking that would postpone its revisions to the Common Rule on the use of human subjects in clinical trials for another six months and opened up discussion on the permitting of three burden-reducing provisions in the 2018 requirements for regulated entities. Read More
Sixteen Democratic and independent senators wrote to HHS Secretary Alex Azar urging him to negotiate lower prices for the opioid overdose reversal drug naloxone. Read More
An FDA advisory committee voted unanimously to recommend approval of a drug for Lennox-Gastaut syndrome and Dravet syndrome that, if approved, would be the first FDA-approved cannabis-derived product, GW Pharma’s NDA for a cannabidiol oral solution. Read More
A California appeals court revived a lawsuit against GlaxoSmithKline in which the plaintiffs claimed the company failed to properly warn non-English speakers about the risks of its antidiabetic drug Avandia (rosiglitazone). Read More
Drug manufacturers found to be fueling the opioid crisis would face marketing limitations and stiff fines under legislation introduced by Sen. Bernie Sanders (I-Vt.). Read More
The Drug Enforcement Administration proposes to limit the production of opioids when setting production quotas by taking into account how often the prescribed drugs are illegally diverted from the individuals for whom they were prescribed. Read More