Many thanks to Alec Gaffney of Regulatory Focus for pointing out that the FDA just published their annual list of draft guidances that they anticipate will be published before the end of 2013. Of course, no guarantees come with it. In fact, they included the anticipation of Track & Trace guidance in last year’s list as well but nothing was published (See “FDA To Publish Track & Trace Standard By Year End“). That’s why it’s not surprising that it’s on the list again this year.
The FDA list seems to come out earlier each year. Considering that the Track & Trace guidance was included on last year’s list, perhaps it will be published in the near future. I’m not holding my breath, but it sure would be an interesting addition to the current situation in California where Continue reading InBrief: FDA Again Says It Plans To Publish Track & Trace Guidance By Year End