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The gulf in expectations and goals exposed in the first FDA
Drug Supply Chain Security Act (DSCSA) Public Meeting back in August (see “ FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “ HDA Schools FDA On DSCSA”) was still visible in the second meeting last week. There is still one more announced meeting scheduled for February 28, 2018 for the FDA and the industry to align (see “ FDA Announces New DSCSA Pilot Program and Public Meeting Series”). Based on my observations at these first two meetings, I’m not going to hold my breath. The FDA is likely to announce more meetings in 2018.
The FDA did adjust their position on at least one thing after the August meeting.
Continue reading FDA DSCSA Public Meeting #2, Still A Gulf
There is a reason so many RxTrace essays have something to do with the Healthcare Distribution Alliance (HDA) (I won’t list them all, but here are two recent ones: “ HDA Traceability Seminar: RxTrace Future Topic List Explodes” and “ HDA Schools FDA On DSCSA”). It’s because they have their fingers in just about everything related to the US pharma supply chain’s preparation for compliance with the Drug Supply Chain Security Act (DSCSA). HDA members are literally in the “center” of the supply chain, and the organization is at the center of many of the most important initiatives related to meeting the DSCSA, including their Origin master data sharing service (see “ Dawn of HDA’s Origin, The Key to DSCSA Compliance”), their future Verification Router Service (VRS) (see “ First Meeting of the HDA Verification Router Service Task Force”), and they hold the most important DSCSA conference every year (see “ FDA Speaks About DSCSA At HDA”). And their HDA Research Foundation now conducts the most important manufacturer DSCSA serialization readiness survey. They just published the latest one. Let’s take a look at it. Continue reading HDA’s 2017 Manufacturer Serialization Readiness Survey Results
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of
Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.
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