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FDA missing more approval target dates as COVID slows inspections

October 19, 2021


Hamstrung by the demands caused by the COVID-19 pandemic, the FDA is missing more PDUFA targets. A pair of companies says the agency won’t be able to meet drug reviews as previously scheduled.

The first, Avadel Pharmaceuticals, had a target action date of Oct. 15 for its candidate to treat narcolepsy—submitted in February—but was notified by the agency that won’t happen. Without elaborating on the cause for the delay, the company said the agency would set a new target action date “as quickly as possible.”

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