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
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 Continue reading FDA To Hold DSCSA Pilots Workshop
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel
and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating
the positions of any company, organization or individual other than Dirk Rodgers.
RxTrace, a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance.
Contact Us | Privacy Statement
Copyright © 2009-2020 Dirk Rodgers Consulting, LLC. All Rights Reserved.
RxTrace is a registered trademark of Dirk Rodgers Consulting, LLC
L, A, S, C