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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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More from United States

Only One ANDA Was Submitted To The US FDA During The Shutdown; It Should Have Been None

 
• By Derrick Gingery

The FDA told the Pink Sheet an ANDA managed to be submitted during a period when no new ANDAs could be accepted.

Real Savings: Medicare-Negotiated Discounts On Cancer Drugs Range From 40%-60%

 
• By Cathy Kelly

Because they are not heavily rebated already, the discounts on four cancer treatments and a trio of other specialty drugs may benefit patients and the government more than others in the IPAY 2027 class.

Trump’s Semaglutide Most Favored Nation Price Will ‘Supersede’ Medicare MFP

 
• By Cathy Kelly

The Medicare negotiated price is slightly higher than the Most Favored Nation price recently announced by the Trump Administration.

AI Boosts Parkinson’s Disease Cell Therapy Development

 
• By Bridget Silverman

Aspen Neurosciences and BlueRock Therapeutics see hope for artificial intelligence to improve the quality of cell therapies to replace dopaminergic neurons in Parkinson's disease.

More from North America

US FDA Approves First Reformulated Rx Ranitidine, Five Years After Withdrawal

 
• By Malcolm Spicer

The FDA included storage and handling instructions common in labeling in its approval announcement, suggesting concerns remain about the potential for NDMA to form after products are distributed.

As US FDA Turns: Can Makary, Prasad And Pazdur Make It Work?

 
• By Michael McCaughan

The FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad, and Commissioner Martin Makary get along?

Obscure User Fee Provision Gives Generic Drug Sponsors More Time To Pay Fees Post-Shutdown

 
• By Derrick Gingery

ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.