Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Each Drug Establishments (Registrants*) registered with FDA must provide information on amount of each listed drug manufactured to Agency under Section 510(j)(3) of the FD&C Act. This support agency’s efforts to reduce drug shortage risks. The requirement applies to each listed drug a registrant manufactures for commercial distribution, including unfinished drugs and APIs (human and veterinary). FDA has published the final guidance to assist registrants of drug establishments in submitting the reports to FDA.
Time line for submitting 2023 calendar year reports is not later than July 31, 2024, with reports for subsequent years recommended to be submitted no later than March 31 of the following calendar year. Registrants should submit reports via the NextGen Portal, available at edm.fda.gov. FDA is updating the CARES Act Amount Information Reporting application in the NextGen Portal. Those reporting the information to FDA till 22 Feb 24, shall use the current version of the CARES Act Amount Information Reporting application. From February 26, 2024, the reports shall be submitted using the updated application and submission formats.
*Registrant means any person that owns or operates an establishment that manufactures, repacks, relabels, or salvages a drug,
FDA has issued a final Level 2 Technical Conformance Guidance for submitting reports on the amount of Listed Drugs and Biological Products. The Guidance describes how to submit reports through FDAs NextGen Portal, different methods for submitting the reports and data elements to be included in the report. (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-amount-listed-drugs-and-biological-products-technical-conformance-guide?)
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