FDA Announces Webinars on Reporting Amount of Listed Drugs and Biological Products

FDA is announcing the availability of two new webinars describing how to use the NextGen portal to report the annual amount of listed human

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA Announces Webinars on Reporting Amount of Listed Drugs and Biological Products   FDA is announcing the availability of two new webinars describing how to use the NextGen portal to report the annual amount of listed human and animal drugs and human biological products that an establishment manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for commercial distribution. All registrants of drug establishments or their authorized agents should use the portal to submit annual reports as required under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, as added by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).    One webinar provides information to users on how to upload data from a comma-separated values (CSV) file to create and submit a CARES Act Amount Information report to the FDA, while the second describes how to manually enter the data. Both are expanded versions of the original reference guide published in October 2021.    CARES Act Amount Information Reporting: Uploading Data from a CSV File CARES Act Amount Information Reporting: Uploading Data from a CSV File  CARES Act Amount Information Reporting: Entering Data Manually CARES Act Amount Information Reporting: Entering Data Manually  The reported data will improve FDA's visibility into the drug supply chain and will help the agency identify, prevent, and mitigate drug shortages. Reports for calendar year 2020 should be submitted no later than February 15, 2022, and reports for calendar year 2021 should be submitted no later than May 16, 2022.  Links to the portal, draft guidance, technical conformance guide, and other relevant information are available at Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts: Reporting the Amount of Listed Human and Animal Drugs and Human Biological Products Manufactured  Technical support questions regarding the submission process should be sent to EDMSupport@fda.hhs.gov. For questions regarding report content, please contact (CDER)  DrugVolumeReporting@fda.hhs.gov, (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010, or (CVM) Office of Surveillance and Compliance, 240-402-7082 or CVMSurveillance@fda.hhs.gov, as applicable.     Learn More The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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