Yearly Archives: 2016

FDA Guidance, UDI

FDA Considering A Delay Of A Small Part Of The UDI Rule

1622-468x60_AprilFor 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  This time it was a draft guidance for comment on a proposed delay in enforcement of a small part of the Unique Device Identification (UDI) final rule.  I’ve seen a lot of mentions around the internet about this new FDA posting but none of them really explain it very well (including the FDA).  I’d like to take a stab.

Way back in around 1970 the FDA created a numbering system for drugs and one for devices.  The one for drugs Continue reading FDA Considering A Delay Of A Small Part Of The UDI Rule →

FDA Guidance

FDA Announces OMB Approval Of One DSCSA Draft Guidance

omb-logoIt’s funny.  Here we are waiting for the FDA to publish four new Drug Supply Chain Security Act (DSCSA) guidance documents (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?“), when an unexpected notice is published about an older draft DSCSA guidance document.  When I first looked at the title of the notice I had to read it four times before I could get myself to believe what I was seeing.

That’s right, this morning the FDA Continue reading FDA Announces OMB Approval Of One DSCSA Draft Guidance →

DSCSA

Announcing: The Second Edition of The Drug Supply Chain Security Act Explained

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DSCSA2ndEditionAdImageThis past week I have been on a vacation with my family in the Caribbean so I do not have a topical essay for you this week, except to announce the availability of the second edition of The Drug Supply Chain Security Act Explained.  The full title is “The Drug Supply Chain Security Act Explained: Second Edition, Plus Explanations Of Key FDA DSCSA Guidances”.  This time the book is available as a paperback and at the much more affordable price of only US$59.99.

I am working on Continue reading Announcing: The Second Edition of The Drug Supply Chain Security Act Explained →

GS1 General Specification

GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care

GS1_logoMedical 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 →

FDA Guidance

Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?

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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? →

India

India Posts New Deadlines (Again) For Serialization Of Drug Exports


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 →

Deadlines

‘An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?’, Again

Dear FriendI 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 →