CDER NEXT GEN PORTAL

CDER NEXT GEN PORTAL

FDA announces launch of option to submit manufacturing capacity data in CDER NextGen Portal

Today, the U.S. Food and Drug Administration announced the launch of a manufacturing capacity option within the Center for Drug Evaluation and Research (CDER) NextGen Portal. As part of ongoing efforts to support product development and availability in response to COVID-19, CDER is collecting additional manufacturing capacity information from applicants for Investigational New Drugs (INDs) to treat COVID-19.  CDER NextGen Portal users will be able to submit manufacturing capacity data to the FDA to analyze and support manufacturing efforts for CDER products to treat or prevent COVID-19. The portal captures information about the specific IND, manufacturer, production rates, treatment courses, and allocations.  Information on registering for a CDER NextGen Portal account is listed within the CDER NextGen Portal User Registration Guide. Current CDER NextGen Portal users will be able to click on the “Manufacturing Capacity” link on the home screen. Additional information about submitting manufacturing capacity data is also available in the CDER NextGen Portal Reference Guide, and in the Frequently Asked Questions. For assistance with registering for an account or technical issues within the CDER NextGen Portal, users should email CDER Platform Support.