I was initially disappointed in the FDA Drug Supply Chain Security Act (DSCSA) Pilots Workshop that was held at FDA headquarters last week, but in the end, the outcome appeared to fit the need. Going in, I knew not to expect the FDA to convey any information to the attendees, so that is not why I was disappointed. I attended the public DSCSA workshop they held back in May of 2014 so I already knew their typical approach for workshops like these (see “The 2014 FDA DSCSA Workshop”). I knew that the purpose of the workshop was to inform the FDA, not to inform the attendees. I would estimate that about one out of every four attendees were expecting the opposite, and I would bet a significant percentage of those had not even read the DSCSA once. But that’s not why I was disappointed.
I was initially disappointed because Continue reading The 2016 FDA Pilots Workshop