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Home » Lehigh Valley Technologies to Settle Claims it Gamed User Fee Waivers
Lehigh Valley Technologies to Settle Claims it Gamed User Fee Waivers
March 1, 2019
Pennsylvania drugmaker Lehigh Valley Technologies agreed to pay $4 million to settle allegations of a conspiracy to illegally evade paying NDA fees.
The FDA grants waivers of user fees for small businesses submitting their first application, after considering any affiliates that may have already received a waiver.
According to the U.S. Attorney for the Eastern District of Pennsylvania, Lehigh received a waiver for its oxycodone hydrochloride NDA but then went on to secure two more waivers for NDAs relating to potassium chloride for oral solution.
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