Global Regulators Recommend Track & Trace Interoperability Features
Drug Track and Trace at a global level. Will it work?
Search Results for: interoperability
PDSA’s Proposal for Governance of DSCSA Phase II Interoperability
PDSA’s first two white papers explain their vision for EDDS interoperability and propose a new organization to govern it.
Does Interoperability Change In 2023?
The FDA thinks it might, and I hope it does. What do you think?
InBrief: Pharma Supply Chain Leaders, Stop Throwing Interoperability Under The Bus
During the report out and follow-up discussion at last week’s FDA Drug Supply Chain Security Act (DSCSA) Pilots Workgroup (see “The 2016 FDA Pilots Workshop”) I heard an example of the industry throwing interoperability under the bus. That is, setting us all up for major complications down the road that could easily be avoided if … Continue reading InBrief: Pharma Supply Chain Leaders, Stop Throwing Interoperability Under The Bus
Interoperability And The DSCSA
I just arrived home from a vacation in Aruba so I missed out on the winter weather many of you experienced last week. Here are a few pictures to help warm you up! While I was in Aruba I spent some time thinking about interoperability as it applies to the provisions of the U.S. Drug Supply … Continue reading Interoperability And The DSCSA
InBrief: RFID and Barcode Interoperability
There is a new and valuable resource available for anyone who needs to make use of both GS1 RFID and GS1 barcodes–or even just one or the other–on any product or shipping container and in any supply chain. It is called “RFID Bar Code Interoperability, GS1 Guideline” and it is available as a free PDF download … Continue reading InBrief: RFID and Barcode Interoperability
FDA Official Will not extend the 2023 deadline
Deadline will not be extended As reported by the Regulatory Focus, the FDA will not delay the interoperability deadline for the DSCSA 2023 deadline. You can for sure group the saleable returns requirements as well. The US Food and Drug Administration is working “full tilt” towards implementing requirements calling for manufacturers and trading partners to … Continue reading FDA Official Will not extend the 2023 deadline
The FDA’s New Guidance for 2021 Explained
As the premier regulatory body for ingestible products in the United States, the FDA (Food and Drug Administration) is responsible for safeguarding public health through safety measures, guidance, and regulations. The importance of the FDA’s job cannot be stressed enough, and in the current global health crisis we find ourselves in, this responsibility is even … Continue reading The FDA’s New Guidance for 2021 Explained
