FDA Unveils NextGen Portal for Reporting of Drugs Volume Data

After a delay in 2020, the FDA has launched its NextGen Portal for drug manufacturers to use for reporting volume data for drugs and biologics.

The portal is part of the Coronavirus Aid, Relief and Economic Security (CARES) Act, along with two guidances that offer details on how to structure the reporting.

The CARES Act established new reporting requirements for drug manufacturers meant to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs.

Drugmakers are now required to report manufacturing volume data to FDA, including the amount of each drug that was manufactured, prepared, propagated, compounded or processed for commercial distribution, according to the agency.