Day: October 12, 2023

Earlier this year, Pfizer suddenly dropped 3500 patients participating in a clinical trial to evaluate its vaccine for Lyme disease citing violation of Good Clinical Practices (GCP) at its CRO vendor. This week, the CRO announced that it was audited by FDA inspectors who found no violations. So, did Pfizer make the wrong decision to … Read more

Animal studies are critical for demonstrating the safety of a product prior to the initiation of human clinical trials. Clinical trials will not be allowed to proceed by the FDA if any major product-related safety issues are observed in animal studies. But did Elon Musk’s company get a break from this policy or lie to … Read more