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User Fee Extensions Are Key To CDER's First Cycle Review Success

 
• By Bridget Silverman

Major amendments are replacing complete response letters when FDA has a problem with an NDA.

FDA's outstanding review efficiency under the PDUFA V review program is made possible in part by frequent use of major amendments, analysis of Center for Drug Evaluation and Research approvals of new molecular entities and novel biologics shows.

CDER approved 45 novel agents in 2015, a 19-year high. The first-cycle approval rate of 87% is also a historic...

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• 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.

More from North America

Trump Administration Closer to Unprecedented Drug Price Transparency Requirements

 
• By Tim Casey

New rules requiring more granular drug pricing data to be disclosed in machine-readable files will go into effect in 2026.

Orphan Drug Relief Still In Budget Bill But Uncertainty Remains

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

 
• By Francesca Bruce

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.