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FDA Announces Availability of Portal and Draft Guidance on Reporting Amount of Listed Drugs and Biological Products

Today, FDA is announcing the new use of a NextGen Portal for reporting 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).

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.

FDA has also issued two draft guidances to assist registrants of drug establishments in reporting the amount of listed drugs and biological products.....[FDA]



AIFA - Gestione telematica istanze e atti emessi dall’Ufficio GMPMED. Avvio della I Fase dal 17 gennaio 2022

L’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (Ufficio GMPMED), allo scopo di ottimizzare...



“CEP of the future”: project update

The consultation phase of the project to design the Certificate of suitability to the monographs of...



Industry seeks delay for reporting manufacturing volume data

Drugmakers and active pharmaceutical ingredient (API) suppliers say they need more time to set up...



Pharmaron Acquires API Manufacturing Facility in UK from Recipharm

Continues to strengthen global chemistry and manufacturing capabilities and capacities.