CDER’s NextGen Portal now accepts manufacturing capacity submissions

Regulatory NewsRegulatory News | 06 October 2020 |  By 

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.
Drug allocation information is provided by filling out a series of matrices specifying dosage forms per kilogram of drug substance, allocation of drug substance and treatment course allocation.
During the public health emergency of the COVID-19 pandemic, CDER is gathering more information about manufacturing capacity. “This solution provides a way for organizations to submit data related to manufacturing capacity to the FDA to analyze and support manufacturing efforts for potential vaccines and therapeutics such that there is a capability for mass production to meet the population need,” according to the reference guide for manufacturing capacity submission.
An accompanying set of frequently asked questions provides further guidance for manufacturers in the particulars of submitting manufacturing capacity through the NextGen Portal.
Those currently registered with the CDER NextGen Portal will see a link for “manufacturing capacity” on the home screen.  Submission of manufacturing capacity is voluntary, but CDER “strongly encourages” this action in support of the agency’s response to COVID-19, says the reference guide.
NextGen reference guide


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Tags: coronavirus, FDA, US

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