Development and Regulation of Abuse-Deterrent Opioid Medications – FDA Public Meeting
The FDA is hosting a public meeting on October 30 and 31, 2014 to discuss the development, assessment, and regulation of abuse-deterrent formulations of opioid medications. The meeting will focus on scientific and technical issues related to the development and in vitro assessment of these products, as well as FDA’s approach towards assessing the benefits […]
Read MoreNew report sheds light on adolescent substance use
According to a report published yesterday by SAMHSA, the number of teenagers from age 12 to 17 smoke cigarettes on a average day is over three-quarters of a million. In addition, typically over a half-million smoked marijuana and almost a half-million drank alcohol. SAMHSA Administrator Pamela S. Hyde states that “This data about adolescents sheds new light on […]
Read MoreFDA Offers Draft Guidance on Abuse-deterrent Opioids
The U.S. Food and Drug Administration today issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties. It describes the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated by the […]
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