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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 agency said in a Federal Register notice announcing...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
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The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

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 Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.