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On February 20, 2024 the FDA released a letter titled “Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions … reminding sponsors to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA.”
Third-party labs are going through a period of mergers and acquisitions. Equity groups Waters Street and Leonard Green purchased, and are struggling to integrate, labs to create entities capable of servicing the full phase of FD&C development and commercialization.
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What this means is that when interacting with a third-party lab, if they are cGMP compliant, there will always be chaos lurking in the background. I’ve seen PhD principal chemists leave to play professional hockey, make kids video games, and open a dance club, all early in their careers. And so, in the middle of your project analysts, QA specialists, etc. will likely be leaving. How do you pick the right lab?
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