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Inside The ANDA Parking Lot

 
• By Derrick Gingery

A firm will take ownership of US ANDAs from manufacturers unwilling to pay program fees or withdraw the approved generic drug application; is it a novel concept allowing future marketing options or simply fee avoidance?

ANDA Parking only sign in Parking lot

In response to complaints about high generic drug user fees, Tanya Dobash erected a parking lot.

The ANDA Repository allows approved abbreviated new drug applications to sit in suspended animation until their owners are ready to market them. Dobash will take possession of an application and...

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More from Biosimilars & Generics

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• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

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

 
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