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?