FDA will introduce blockchain in the process of analysis and recall of medicines

FDA will introduce blockchain in the process of analysis and recall of medicines

The U.S. Food and Drug Administration (FDA) plans to implement a blockchain to improve the process of analyzing and recalling drugs.

FDA Chief Deputy Commissioner Amy Abernethy said the agency is committed to streamlining the interactions between healthcare providers, drug manufacturers, and regulatory agencies. According to her, the FDA plans to deploy the use of AI, APIs and blockchain as part of its modernization efforts, which may affect the process of analyzing new drugs.

“I want the FDA to tidy up our own technical center so that technologies can be implemented and we become more flexible and efficient. We need to have common interfaces with the industry so that we can transfer data between our organizations, as well as conduct joint checks and other operations, ”Aberneti said.

“The ability to track the process down to the source allows cross-validation of workflow solutions. In this sense, an immutable registry can be used to guarantee the quality of data coming from a number of sources. ”

Abernathy also referred to a communication system in which regulators are provided with real-time information and data. This will speed up the verification process, as FDA agents can simultaneously communicate with drug manufacturers.

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In addition, improved surveillance of medical products will help “determine that certain drugs should be withdrawn, and the label should be changed for some products.” Abernathy noted that with improved data streams, medicine could become more patient-centric. In conclusion, she added that the system will be deployed in a “month or two.”

In June, it became known that the FDA, IBM and Merck will implement blockchain in the supply chain of medicines. In addition, the FDA Commissioner had previously proposed using blockchain in supply chains.


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