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Insights and Issues From FDA Advisory Committee Meetings on Abuse-Deterrent Opioids

February 28, 2018

It is the current policy of the US Food and Drug Administration (FDA) to convene expert Advisory Committees to provide input on key regulatory decisions regarding opioid products, including approval and labeling of opioid abuse-deterrent formulations (ADFs). Advisory Committee meetings on ADF opioids consider whether the laboratory and clinical data…

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Getting Approval for Abuse-Deterrent Opioids in the Era of an Opioid Epidemic

February 14, 2018

More than 42,000 Americans died from an opioid overdose in 2016. The number of deaths each year from opioids now surpasses the number of Americans who died each year from AIDS at the height of that epidemic in the mid-1990s. While misuse and abuse of prescription opioid medications is a…

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The Debrief on Briefing Documents: How to Maximize Your Briefing Book for FDA Advisory Committee Meetings

December 7, 2017

At an FDA Advisory Committee (ADCOM) meeting – one of the most important days in a product’s development – Sponsors typically have no more than 75 minutes to credibly and persuasively explain their entire development program. The stakes are high because the committee plays a key role in influencing the…

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The New FDA Focus: “Business as Usual” Now Includes Paying Attention to the Cost of Drug Development

October 19, 2017

In the “old days” (aka, last year), the FDA rarely mentioned the “cost of drug development.”  The line between research and development (R&D) costs and regulatory was clear and not to be breached.  And when the term “price” entered the vernacular, FDA officials were consistent in their message that the…

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