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INDUSTRY RESOURCES

05
Dec
CRS Lawsuit: Does FDA Guidance Require More Clarity?

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.

Posted in:Clinical,FDA,
04
Dec
Best Practices For Data Integrity Oversight At Your Contract Manufacturer

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.

Posted in:Clinical,FDA,Manufacturing,
Tags:contract manufacturing,data integrity,GMP,
blockchain
29
Nov
Blockchain & The Pharma Supply Chain — Beyond DSCSA Compliance

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.

Posted in:FDA,Manufacturing,
Tags:counterfeit,IEEE-SA,supply chain,
28
Nov
10 Simple Steps To Selecting The Right CMO

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

Posted in:Manufacturing,
Tags:CMO,strategy,
28
Nov
5 (Fairly Simple) Statistical Analysis Plan Elements To Implement In Your Clinical Study

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.

Posted in:Clinical,
27
Nov
3 Keys To Scale-Up CAR T-Cell Therapy Manufacturing

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.

Posted in:FDA,Manufacturing,
Tags:cells,gene therapy,

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