Newsletter - October 12, 2023
Did Elon Musk Get a Pass from FDA For His High-Risk Device Trial?
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 the FDA?...Read More
Did Pfizer Discontinue 3500 Patients on a Clinical Trial in Error?
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...Read More
Did Elon Musk Get a Pass from FDA For His High-Risk Device Trial?
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 the FDA?...Read More
Did Pfizer Discontinue 3500 Patients on a Clinical Trial in Error?
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...Read More
