Two-For-One FDA Guidance Docs

Back in February I noted the steep drop in public inspection documents posted by the FDA immediately after President Trump took office (see “One Immediate Impact of President Trump On The FDA”).  For that essay I created a graph that clearly showed the steep drop.  But that was only one month after the new President took office.  What has happened since then?  This week I updated my graph so we can see how things are progressing.  Continue reading Two-For-One FDA Guidance Docs

Serial Number Bonding

There are some discontinuities between the needs of the industry for meeting serialization regulations around the world and certain GS1 standards, including their Electronic Product Code Information Services (EPCIS) and Core Business Vocabulary (CBV) standards.  I’ve already pointed out the issue of EPCIS expecting everyone who uses it to possess, by default, a GS1 Global Location Number (GLN) (see “GLN: The Lowly Identifier That Could Kill The Use Of EPCIS For Pharma Regulatory Compliance”).  Here is one more. Continue reading Serial Number Bonding

FDA Delays UDI and FSMA: What About DSCSA?

Image of November 27, 2017 calendarA few weeks ago I predicted that the FDA would soon announce a delay in enforcement of the Drug Supply Chain Security Act (DSCSA) November 27, 2017 deadline for serialization of drug packages (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”, see also “Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance”).  As I said, I don’t have any “inside information”, I’m just looking at the evidence that we can all see.  I provided links to the public information I used for evidence so you can decide for yourself.  Don’t just take my word for it.  It is entirely speculation.

Now there is new evidence that the FDA is in a “delay” mood these days.  In the last 4 business days the FDA has Continue reading FDA Delays UDI and FSMA: What About DSCSA?

New Must-Read DSCSA Resource

Last week, GS1 US published a free DSCSA resource that every RxTrace reader must have.  It’s called “Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA” and it can be downloaded free after registration.  Do it now, then come back and finish reading this essay.

The document is 42 pages in PDF form and it Continue reading New Must-Read DSCSA Resource

Brazil Publishes RDC-157 To Regulate 2017 3-Lot Pilot

ANVISA logoOn May 11, 2017, ANVISA formally published RDC-157/2017 that will serve as the regulations for their 3-Lot Pilot that is to take place in 2017.  We’ve been expecting this new RDC around this time because they were required by the recent Law Number 13.410 of December 28, 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”).  ANVISA also held a “public consultation” to allow the public to review and comment on an earlier draft of what is now RDC-157/2016 (see “ANVISA Reveals Draft Serialization Regulation and Asks For Comments”).  The newly adopted RDC-157 is clearly intended to guide the pilot and then ANVISA intends to update it as part of their analysis of the pilot results.  They will likely go through another public consultation before they make it a final regulation that all companies will need to follow.  Bottom line, if you are not part of the 3-Lot Pilot, don’t start implementing a solution until Continue reading Brazil Publishes RDC-157 To Regulate 2017 3-Lot Pilot

Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance

FDA official, Connie Jung PhD, Senior Advisor for Policy, spoke at the International Society of Pharmaceutical Engineering (ISPE) Serialization Workshops event yesterday to provide background on the Drug Supply Chain Security Act (DSCSA).  I used the opportunity to ask her a number of questions regarding some of the things I based my prediction in Monday’s essay that the FDA will announce a delay in the DSCSA in the next three weeks (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”).  The timing was perfect, and when I registered for the event, I didn’t even know the FDA was on the agenda.

Here’s the backstory. Continue reading Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance

FDA Tea Leaves: Are They About To Delay The November Deadline?

Drawing of tea leaves to be read
Can you read these?

I don’t have any hard evidence, but there are some interesting things out there that just might point to a coming delay in the Drug Supply Chain Security Act (DSCSA) November 27, 2017 deadline for drug manufacturer serialization and electronic transaction data exchange.  Let’s call them “tea leaves”, and let me attempt to “read” them.  They might turn out to be meaningless, so don’t take any action based on such speculation.  And if you know something more, or interpret something differently, leave a message.

During the Cold War the U.S. government and the press attempted to figure out what was going on in the Soviet Union by paying attention to who was standing next to whom during military parades.  Our exercise might see a little like that. Continue reading FDA Tea Leaves: Are They About To Delay The November Deadline?

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