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Generic Drugs: First-Cycle Review Times Improve, But Hundreds Of ANDAs Still Pending

 
• By Derrick Gingery

US FDA cut first-cycle review time 46% between fiscal year 2013 and FY 2015, but more than 900 ANDAs still awaited review by end of 2016.

FDA entrance sign 2016

The US FDA has dramatically improved its generic drug application review times, but still had about one-third of all applications submitted still pending at the end of 2016.

A Government Accountability Office report on the generic drug user fee program released in June found that the average time needed for the first review cycle of an...

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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.