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Congress Seeks Tougher FDA Approval Process for Opioids
New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the FDA.
New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the FDA.
The bill, the FDA Accountability for Public Safety Act, is a response to FDA's regulation of opioid painkillers, and specifically one known as Zohydro. The drug was approved in October 2013 as a pure hydrocodone product lacking any physical characteristics which could make it more difficult to misuse or abuse. Zohydro's approval was considered somewhat unusual in that FDA bucked the advice of its advisory panel, which cited the drug's potential for abuse when recommending against its approval.
Zohydro's approval was an immediate source of controversy for FDA and the drug's manufacturer, Zogenix.
Read more at Regulatory Affairs Professional Society: http://bit.ly/1zDpseh
Frameworks for Advancing Health Equity: Urban Health Outreach
May 9th 2024In the series debut episode of "Frameworks for Advancing Health Equity," Mary Sligh, CRNP, and Chelsea Chappars, of Allegheny Health Network, explain how the Urban Health Outreach program aims to improve health equity for individuals experiencing homelessness.
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Study Highlights Significant Increases in Utilization, Spending on DMD Drugs in Medicaid
May 17th 2024The findings add to recent research on the growing utilization, expenditure, and prices of Duchenne muscular dystrophy (DMD) therapies in the current landscape, an area health care policy could potentially address.
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