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How US FDA And Industry Are Looking To Navigate New Supply Chain Data Reporting Requirements

 
• By Derrick Gingery

FDA Commissioner Hahn says industry needs to work with the agency to establish a link to more detailed supply chain information.

Sterile bottles and ampoules on the dispensing line.Sealed ampoules with medicine.Sterile capsules for injection. Bottles on the bottling line of the pharmaceutical plant.
CARES Act supply chain reporting will begin 23 September, but industry is waiting for guidance on standards and format. • Source: Shutterstock

US Food and Drug Administration Commissioner Stephen Hahn wants industry to help create a required data stream updating the status of the supply chain with questions still unanswered about the system and format envisioned.

Hahn said during a session of the Biotechnology Innovation Organization’s recent virtual international convention that the agency needs to better understand the pharmaceutical supply chain and industry capabilities within it....

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