FDA convenes public meeting amid DSCSA resistance

Faced with growing pushback against some of its guidance on the medicines traceability scheme for the US, the FDA has convened another public meeting to discuss the plans.

The meeting will be held on October 5 and will discuss enhanced drug distribution security (EDDS) requirements that go into effect in 2023 under the Drug Supply Chain Security Act (DSCSA). It will be hosted by Connie Jung, FDA senior advisor for policy, and Abha Kundi, regulatory counsel for the agency's division of supply chain integrity.

The announcement of the meeting comes shortly after an organisation representing wholesale distributors in the US has asked the FDA to abandon its recently-published EDDS guidance, saying the model proposed "does not exist, is not required by the statute, and…cannot be built in time to meet the 2023 deadlines."

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