Dear FDA, Thanks for inviting me to your DSCSA Pilot Party this week. I look forward to visiting you at your Silver Spring home so we can catch up on what’s been happing in our lives recently. I’m glad you are thinking more about the Drug Supply Chain Security Act (DSCSA) lately. I am too. … Continue reading An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon
For the second time this week, the FDA posted something related to the things I pay the most attention to. Earlier this week it was about the DSCSA. This time it was a draft guidance for comment on a proposed delay in enforcement of a small part of the Unique Device Identification (UDI) final rule. … Continue reading FDA Considering A Delay Of A Small Part Of The UDI Rule
Medical device manufacturers have a choice of standards to use when identifying their products for the U.S. market. The FDA’s Unique Device Identification (UDI) rule allows them to select from any identification standards organization (referred to as a “number issuing” agency) that is accredited by the Agency for that purpose. So far, three organizations have … Continue reading GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care
Until the Drug Supply Chain Security Act (DSCSA) was passed as part of the Drug Quality and Security Act (DQSA) last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), companies could use whatever code they wanted to refer to the prescription drug products in supply chain operations and for their own … Continue reading The DSCSA, the NDC, Inventory Management, GS1 GTINs…and Turkeys
There is a lot of angst in the pharma community right now about the fast approaching DSCSA first deadline for the exchange of transaction data, but the medical device community is dealing with an even earlier deadline: the September 24, 2014 deadline for UDI on class III medical devices. The FDA UDI web page lists … Continue reading UDI Deadline For Class III Medical Devices Quickly Approaching
Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future. Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how … Continue reading The Future of Healthcare Supply Chain Security
Over the last five years the larger companies in the U.S. pharmaceutical supply chain have increasingly aligned around GS1’s Electronic Product Code Information Services (EPCIS) standard for holding and communicating serialization-based events. The hope and expectation by many of these manufactures and others in the supply chain is that EPCIS will be the standard that … Continue reading Will Use Of EPCIS Force Everyone To Use GS1 Identifiers?
To be honest, I was somewhat surprised when Jay Crowley announced during last week’s UDI Conference that the U.S. FDA had published the final rules for Unique Device Identification (UDI). Its publication starts the clock on a host of new requirements designed to identify most medical devices in the U.S. market with the same standard … Continue reading UDI And The Approaching End Of The NDC
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