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Gabapentin Petition Could Give FDA Opportunity to Revisit Tradeoffs In Opioid Oversight Debate

 
• By Sarah Karlin-Smith

Public Citizen’s request to place gabapentin on DEA’s controlled substances list may be a test case for how much weight FDA plans to give to broader public health impacts of drug approvals as opposed to the risk-benefit calculus for individual patients for whom a drug is labeled.

DEA logo on wall
Public Citizen Wants FDA and DEA to place gabapentin in schedule V • Source: Alamy

Public Citizen is petitioning the US Food and Drug Administration and Drug Enforcement Administration to place gabapentin into schedule V of the Controlled Substances Act due to the drug's potential for abuse with serious consequences that include psychological effects, physical dependence, seizures, suicide and overdose death.

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US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 
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Industry Urged To Respond To EU Expectations On Using Animal Testing Alternatives

 
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Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 
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The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.

Mifepristone Filing Supports 2023 US FDA Actions, But Experts Caution Against Overanalyzing

 
• By Sarah Karlin-Smith

Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.

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Brazil’s ANVISA Clarifies Registration Procedures For Biologicals

 
• By Francesca Bruce

Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.

SpringWorks To Make Its Case For Nirogacestat At High-Stakes EMA Meeting

 
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Postmarketing Surprise Is Latest Plot Twist For Novavax’s COVID-19 Vaccine BLA

 
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Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.