As you have read, the FDA has let it slip, with a draft guidance document, that they have decided not to enforce the DSCSA’s November 27, 2017 deadline for manufacturers to apply the new serialized product identifier on drug packages and verification requirements for one year, but it also contains cascading enforcement delays (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”). This is a major move by the FDA and it will have important consequences for the industry. Let’s break it down. Continue reading FDA Delays Enforcement of DSCSA November Deadline: What It Means
A 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?
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?
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.
The industry is rife with rumors that Brazil’s ANVISA has made the decision to push out their serialization deadline for multiple years—and perhaps redefine the requirements. I cannot confirm any of these rumors at this point and I do not recommend acting on rumors. I suggest you continue down the path of meeting the existing, known regulation until—if ever—you get the official word from an official publication of ANVISA. Who knows when that might occur. If/when you see something official, let me know. Continue reading Sponsored: Pharma Serialization Deadlines In Flux
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 wife is not very happy about that!
The reason I am writing directly to you at this time is to ask a question that I hope you are asking yourselves and planning ahead for. Continue reading An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?