USA – CDER’s NextGen Portal now accepts manufacturing capacity submissions

The US Food and Drug Administration (FDA) announced the availability of an online option for sponsors of investigational new drugs to submit manufacturing capacity data.

By registering and going through the Center for Drug Evaluation and Research (CDER)’s NextGen Portal, sponsors can provide the agency with information about the specific investigational new drug (IND) application and the manufacturer, along with details about rates of production, treatment courses, clinical trials and allocations of the drug, according to an announcement from CDER…