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Gottlieb Defends Accelerated Approval, Scorns Access Limits By Payors

 
• By Kate Rawson

US FDA's accelerated approval pathway is more reliable and has better validated biomarkers than a decade ago, commissioner says, arguing coverage limits on AA products are not in the interest of public health.

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US FDA Commissioner Scott Gottlieb is defending the accelerated approval pathway in response to payors who have balked at covering high-priced products cleared under what they perceive to be a lower regulatory standard than the traditional approval process.

Speaking during the National Organization for Rare Disorders’ “Rare Summit” on Oct. 17, Gottlieb acknowledged “some instances” in which payors...

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US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 
• By Bridget Silverman

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 
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Early Support For EMA’s Trial Of US-Style Standards In Non-Clinical Reviews

 
• By Vibha Sharma

An ongoing proof-of-concept study by the European Medicines Agency testing the use of US-style standards for submitting non-clinical raw data in marketing applications has received positive feedback from both industry and regulatory assessors so far.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Tepezza, Amgen's treatment for moderate to severe thyroid eye disease.

More from Pathways & Standards

Early Support For EMA’s Trial Of US-Style Standards In Non-Clinical Reviews

 
• By Vibha Sharma

An ongoing proof-of-concept study by the European Medicines Agency testing the use of US-style standards for submitting non-clinical raw data in marketing applications has received positive feedback from both industry and regulatory assessors so far.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Tepezza, Amgen's treatment for moderate to severe thyroid eye disease.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US