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 been FDA-accredited: HIBCC, ICCBBA and GS1.
ICCBBA has a lock on the identification of Continue reading GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care
Happy Martin Luther King Day!
Congress set the calendar for many different kinds of requirements when it adopted the Drug Supply Chain Security Act, signed by the President back on November 27, 2013. One of those dates was last November 27, 2015, two years after enactment, when the FDA was required to publish four new draft guidances. So far, none of them have appeared (see “FDA DSCSA Deadline Passes Quietly”). Continue reading Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?
Right now we are waiting for major new announcements regarding serialization and tracing requirements in the United States (4 overdue FDA guidance documents), the European Union (final publication of the Delegate Act related to the Falsified Medicines Act), Brazil (major redesign of their regulation), and Russia (first official publication of their regulation). But last week, the India Directorate General of Foreign Trade (DGFT) published a new public notice containing details of the “Implementation of the Track and Trace System for Export of Pharmaceuticals and Drug Consignments”. These details are for drugs made in India but exported to other markets. Continue reading India Posts New Deadlines (Again) For Serialization Of Drug Exports
I hope your holidays were filled with love and cheer. Mine were. It was great. So great, in fact, that I did not have time to write a brand new essay for today. Not much has happened lately since we are still awaiting publications from the FDA, the EC and ANVISA (and others), Instead, here is one of my best essays from 2015, reposted as it appeared on August 31, 2015 without modification (see “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?“). I’m even leaving in the off-season references. If you read this essay back then, you might enjoy it again. If you did not read it back then, I recommend that you read it now. Let me know what you think.
Before we begin, if you have not yet responded to the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz, please to so now. It is open to everyone and the survey will be closed soon.
And now Continue reading ‘An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?’, Again