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FDA warns of possible PDUFA delays due to COVID-19

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FDA may not meet its goals for regulatory decisions during the COVID-19 pandemic, according to guidance published Tuesday.

“With many staff members working on COVID-19 activities, it is possible that we will not be able to sustain our current performance level in meeting goal dates indefinitely,” the agency said. “We anticipate that the New Drugs Program and the Biologics Program may need to allocate resources to focus on certain activities,” including coronavirus-related INDs, NDAs and BLAs.

While FDA said it does not expect to blanket extend PDUFA dates because of the pandemic, the agency will communicate with application sponsors if it expects to miss the goal date.

The guidance also said that all FDA meetings, including PDUFA and advisory committee meetings, will be held virtually. It did not provide a timeline for resuming in person meetings.

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