New App for Reporting Drug Amounts Produced

FDA has created a new CARES Act Amount Information Reporting application for drug establishments (or their authorized agents) to use when submitting annual reports of the amount of listed drugs and biological products produced. If establishments have already submitted their required report for calendar year 2023 using the previous version of the application, they do not need to resubmit using the updated application, the agency says. “However, if you have not submitted your calendar year 2023 report using the previous version of the application, the recommended time frame for submitting calendar year 2023 reports is no later than 7/31/2024, the agency says.

Additionally, FDA has issued a revised Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide. The guide is intended to assist registrants of drug establishments in submitting annual reports.