On March 18, the FDA launched a new portal for patients, consumers and healthcare professionals to report potential drug shortage issues directly into CDER’s NextGen system without creating a NextGen account.
Since 2017, NextGen has been a way for regulated industry to communicate with the FDA, including submitting information on shortages, discontinuations, and anticipated supply disruptions. Non-industry stakeholders without a NextGen account previously reported information about potential shortages to the FDA’s Drug Shortages Staff by email. The new public portal allows anyone to submit shortage information through an online form directly into NextGen.
Expanding access to NextGen’s shortage reporting beyond regulated industry will allow for greater consistency and ease of reporting by outside stakeholders, and greater efficiency in tracking and responding to these reports.
FDA has the portal.
