Search Results for: delegated regulation

DSCSA, EUDR

Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution

As serialization mandates sweep the world you would think that drug manufacturers and repackagers would just deploy one generic “serialization application” and simply turn it on for any drugs that requires it, and turn it off for any that do not.  That’s probably what the legislatures and regulators who create the requirements think.  RxTrace readers know it’s not … Continue reading Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution →

FMD

What Happens To The FMD In the UK After Brexit Day? Seriously, Does Anyone Know?

Friday was “Brexit Day” in the United Kingdom—the last day the UK was a full member of the European Union.  At 11pm London time, the UK entered an 11 month “transition period” that will lead to the full exit on December 31, 2020.  On Wednesday the European Parliament voted overwhelmingly to accept the UK withdrawal … Continue reading What Happens To The FMD In the UK After Brexit Day? Seriously, Does Anyone Know? →

NDC

NDC Nearing Its End, Afflicted by ‘Identifier Failure’

Heart Failure is a human condition that is characterized by several easily identifiable symptoms, including fatigue, difficulty breathing and in its later stages, gurgled breathing.  My mother and my mother-in-law both suffered from heart failure during their decline.  Analogous to heart failure in humans is a condition of an identifier system that is near the … Continue reading NDC Nearing Its End, Afflicted by ‘Identifier Failure’ →

Deadlines

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

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

Predictions

RxTrace Preview of 2016

It’s time to think about what is likely to happen in 2016 with regard to pharma serialization and traceability.  As part of that, let me remind you right off the top to fill out the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz.  You don’t have to be a subscriber  to respond and the … Continue reading RxTrace Preview of 2016 →

EU FMD, EUDA

Insufficient Transitional Measures Doom The FMD-EUDA

The pharmaceutical supply chain in most markets is complex, but in my view, the one in the European Union easily takes the prize for being the most complex of any other.  The addition of unit-level serialization and verification of authenticity to that supply chain over the next few years as required by the Falsified Medicines … Continue reading Insufficient Transitional Measures Doom The FMD-EUDA →

SAP

SAP Makes Bold Move Into Pharma Traceability

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Last week SAP announced the availability of their brand new software module they are calling “SAP Advanced Track and Trace for Pharmaceuticals”, or ATTP.  Pharmaceutical Commerce magazine published an article about it recently that provides the details of what is contained in this new module.  The same issue contained a sponsored article from SAP about … Continue reading SAP Makes Bold Move Into Pharma Traceability →

Deadlines

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

5 Comments

Dear FDA, EMA and ANVISA, How are you?  I’m sure your summer has been busy, just like mine.  Hope you were able to get at least some time away.  I’ve taken most Saturdays off, but the other days of the week have been very full with consulting, and then writing RxTrace essays every Sunday.  You know, the … Continue reading An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish? →