As we saw last fall, the FDA is planning to conduct at least one pilot project in 2016 to fulfill its DSCSA mandate to do so. The pilot should focus on the 2023 DSCSA technologies and processes (see “FDA Looking For Consulting Org To Run DSCSA Pilots“). Today we learned that a pilot will indeed occur this year, and the FDA wants your input into its design and goals. To accomplish that quickly, the FDA will establish a docket next Tuesday for collecting written comments, and a public workshop for collecting verbal comments.
The last DSCSA public workshop run by the FDA occurred on May 8, 2014 (see “The 2014 FDA DSCSA Workshop“). This one will be held on April 5, 2016, from 9 a.m. to 5 p.m. and April 6, 2016, from 9 a.m. to 12:15 p.m. at FDA’s White Oak Campus in Silver Spring, MD. The FDA will post the agenda and relevant materials here by March 29, 2016. There is no registration fee and there will be no on-site registrations.
The FDA says you need to register before March 11, 2016, but the number of registrants will be limited by the size of the room, and based on the interest companies are likely to have in this event, I’d be surprised if they are not forced to cut off registrations much earlier than that. Don’t delay…I’m already registered! To ensure “…broad and varied representation across the pharmaceutical distribution supply chain…”, FDA will probably also eventually limit the number of registrants per company, so make sure you work with your co-workers to figure out who the right people are and make sure they get registered.
Once again, portions of the workshop will be recorded and also webcast live. This works fairly well when there is a speaker at a podium, but not so well when there is discussion from the audience.
The docket for collecting written comments will open soon and the FDA is even suggesting you can submit ideas for the agenda of the workshop. You can submit comments to the docket anytime, before or after the workshop is complete, but it will be closed on April 21, 2016. See the announcement for details on accessing the docket.
I hope to see you there.