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Importation, Pricing Policies Raised Concerns For US FDA's Project Orbis

 
• By Derrick Gingery

Allowing multi-regulator collaboration on oncology application assessment may run into pricing issues if Canada and Australia gain access to novel drugs before European countries, US FDA's Pazdur says.

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Singapore and Switzerland could join Project Orbis soon. • Source: Shutterstock

Richard Pazdur worried that his program allowing simultaneous submission and assessment of drug applications in the US and other countries would be improperly linked to, and potentially damaged by, White House plans to allow drug importation from Canada.

The director of the US Food and Drug Administration's Oncology Center of Excellence also was concerned that ex-US drug pricing...

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Crosstalk On Drug Pricing: Conflicts In Trump Team Rhetoric And Policy

 
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The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.

BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
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HTA Expert Warns Of Escalating Measures If Pharma Fails To Tame Prices

 
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Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.

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Welireg Among Japan Recommendations; Economic Policy Raises Hopes Of Higher Prices

 
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HTA Expert Warns Of Escalating Measures If Pharma Fails To Tame Prices

 
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