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Generic User Fee Transition A Little Bumpy For Contract Manufacturers

 
• By Derrick Gingery

Problems with self-identification process caused by timing of legislative renewal may have affected figures used by US FDA to calculate FY 2018 GDUFA fees.

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Contract manufacturers apparently did not join the US FDA generic drug user fee program's facility self-identification process as smoothly as intended, due in part to unfortunate timing of the legislative renewal of the program that prevented guidance development.

FDA asks generic drug manufacturers to voluntarily report their facilities and associated functions each year to help the agency keep an updated list of where products are made for the...

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US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
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US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
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Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

More from Biosimilars & Generics

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

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• By Michael McCaughan

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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.