The difficulties of conducting manufacturing inspections and review activities in the COVID-19 era seems to be encouraging the FDA to find a response that is less definitive than a complete response letter and less formal than a user fee goal date extension.
Spectrum Pharmaceuticals Inc. became the latest recipient of a “not a complete response” letter upon the 24 October 2020 user fee goal date for Rolontis (eflapegrastim), a long-acting granulocyte...
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