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

 
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The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.

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

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

 
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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.

Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 
• By Bridget Silverman

The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.

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Pharma Still Nervous While Riding Trump’s Tariff Rollercoaster

 
• By Jessica Merrill

The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.

New Medicines Pricing Proposals Would Mean More Uncertainty For Spanish Supply Chains

 
• By Francesca Bruce

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New Measures Can Cut Israel’s Drug Approval Time To Just 70 Days

 
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Israel has introduced a new framework to expedite the marketing approval of medicines, make the country a more attractive destination for drug registration and help reduce drug prices through market competition.