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PDUFA Fees Forced Down For FY 2017 Due To Refund Provision

 
• By Derrick Gingery

Final year of this user fee cycle will include 14% discount, but agency says it is ready for revenue reduction.

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Prescription drug user fees will decrease dramatically in fiscal year 2017 thanks to a requirement forcing FDA to credit revenue in excess of estimates back to industry.

Fees for applications requiring clinical data will drop more than 14% compared to the FY 2016 level to $2.04m, the...

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Stealth Pushes for Faster US FDA Review Of Barth Syndrome Drug As Funds Dwindle

 
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Europe Eyes First Therapies For PSC And cALD In Latest EMA Drug Filings

 
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Norucholic acid and leriglitazone, for treating primary sclerosing cholangitis and cerebral adrenoleukodystrophy, respectively, are among 12 new drugs that the European Medicines Agency has started to review for potential EU marketing approval.

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UK Initiative Steps Up Efforts To Tackle Recruitment Bottlenecks In Dementia Trials

 
• By Anabel Costa-Ferreira

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Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
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Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

Stealth Pushes for Faster US FDA Review Of Barth Syndrome Drug As Funds Dwindle

 
• By Sue Sutter

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