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FDA waives NDA filing fee for pSivida's Durasert microinsert

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The FDA has waived the $2.4 million new drug application filing fee for pSivida’s Durasert 3-year microinsert for posterior segment uveitis, according to a company press release.

pSivida had requested a small business waiver of the Prescription Drug User Fee Act filing fee. The company plans to file the NDA this month.

“FDA’s grant of this waiver enables us to focus our resources on initial preparations for our U.S. posterior segment uveitis launch anticipated in early 2019 and R&D activities in our product development pipeline,” Nancy Lurker, pSivida president and CEO, said in the release.