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Generic Application Quality Showing Signs Of Improvement

 
• By Derrick Gingery

US FDA’s monthly refuse-to-receive numbers for ANDAs are down early in FY 2017, suggesting that sponsor have an increased understanding of the agency’s standards.

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Usually a drop in FDA's generic drug metrics is a cause for alarm, but when it concerns refuse-to-receive actions, it may signal a breakthrough.

The agency's Office of Generic Drugs has reported significantly fewer refusals during the first two months of fiscal year 2017 than had been seen in past years. If the trend...

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• By Dean Rudge

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• By Dean Rudge

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EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.