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The recent announcement that the watchdog group Center for Responsible Science (CRS) has filed a lawsuit against the FDA has raised some concerns in the clinical research community. The lawsuit is regarding the denial of the group’s citizen petition, which was originally submitted in June 2014.
Part 1 of this two-part article addressed FDA warning letter enforcement actions and discussed things that can go awry in these relationships related to data governance and data integrity. In Part 2, we turn our attention to health authority GMP guidance on contractual relationships and best practices that should be considered in this area.
A holistic view of the value of blockchain to the pharmaceutical supply chain takes into account the magnitude of the global counterfeit drug problem; the financial, economic, and social costs of counterfeit drugs; and the positive financial and economic benefits of moving beyond compliance to tackling the issue of counterfeit drugs head-on.
While presenting a webinar on the CMO selection process not long ago, I had a moment of clarity. Even though I didn’t include the following words in 36-point block letters on any slide, I suddenly discovered the essence of the lecture
In this article I will present five often ignored elements of a solid statistical analysis plan that help to address those “what-ifs” and will make troubleshooting the inevitable deviations easier. As you will see, a little thoughtful consideration of what could go awry up front will keep you from pulling out the duct tape and hammer to jerry-rig after the fact.
This has been a tremendous year for cell and gene therapy. In October, the FDA approved Yescarta, a chimeric antigen receptor (CAR) T-cell therapy developed by Kite Pharmaceuticals and recently acquired by Gilead Sciences, becoming only the second gene therapy to be approved in the U.S. This comes less than two months after the FDA approved Novartis’ CAR T-cell therapy, Kymriah.
Thanks to our relationship with LSTI and an outstanding team here at Accelovance, we have built a training program that is able to be leveraged moving forward to address an industry need.
My main reason for taking the course was to re-evaluate quality agreements and how to improve our current template. Coming out of this, I would like to compare a few of our supplier quality agreements against the structure and checklist given in the course to see how they align.
Cook Pharmica LLC
All parts of the training were useful, including the topics of Documentation, Change Control and Revisions. I will now review our current Quality Agreement to make sure the requirements are included, and if not, add them.
I took the course to get a better understanding of FDA requirements. As an ISO 9001 registered organization, we need to control and cooperate with suppliers and this gave me some ideas on more formal ways to do that. The webinar was easy to attend with clear audio.