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Public Meeting on 3D Printing of Anatomic Models

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CDRH and the Radiological Society of North America 3D Printing Special Interest Group announce an 8/31 joint meeting on the clinic...

Coherus Wants Delay in Neulasta Case Discovery

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Patterson Belknap attorneys say that Coherus BioSciences is asking a federal court to delay discovery in a Neulasta patent dispute...

Medtronic Gains Approval for Avalus Aortic Valve

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FDA approves a Medtronic PMA of its new Avalus pericardial aortic surgical valve for treating aortic valve disease.

Animal Drug User Fee Rates for 2018

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Federal Register notice: FDA announces the fee rates and payment procedures for fiscal year 2018 generic new animal drug user fees...

2018 User Fee Rates for Drug Compounders

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Federal Register notice: FDA announces the fiscal year 2018 rates for the establishment and re-inspection fees related to entities...

FDA, TG Therapeutics Agree on Special Protocol for MS Studies

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FDA and TG Therapeutics reach an agreement on a special protocol assessment on the design of two Phase 3 clinical trials for TG-11...

Generic Drug Prices Increasing Over Time

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A National Bureau of Economic Research working paper says more study into how much generic drug prices have increased over time is...

FDA Accepts AstraZeneca NDA for Acalabrutinib

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FDA accepts for priority review an AstraZeneca NDA for acalabrutinib, a highly-selective Bruton tyrosine kinase inhibitor for trea...

User Fee Rates for Animal Drugs

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Federal Register notice: FDA announces the rates and payment procedures for fiscal year 2018 animal drug user fees.

Imbruvica Indication Expanded to cGVHD

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FDA approves Pharmacyclics Imbruvica for a new indication to treat chronic graft versus host disease after failure of one or more ...