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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
Pulmonary Hypertension Subtypes Show Distinct PA Flow Hemodynamics
March 21st 2025Investigators used 4D flow cardiovascular magnetic resonance imaging to search for differences between pulmonary artery (PA) remodeling in pulmonary arterial hypertension and other types of pulmonary hypertension.
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EMBARK Data Show Continued Improvements With DMD Gene Therapy
March 19th 2025Data from the EMBARK trial of delandistrogene moxeparvovec in patients with Duchenne muscular dystrophy (DMD) show that benefits in functional outcomes, gene expression, and muscle imaging persist 2 years after receiving the gene therapy.
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Bustling Gene Therapy Pipeline for Neuromuscular Diseases Brings Thorny Questions to the Clinic
March 18th 2025The rapid development of gene therapy options for treating neuromuscular diseases has created new therapeutic options but also logistical hurdles and a need for complex discussions between clinicians and families.
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