Newsletter - March 2, 2023
FDA is Out of Touch With Patients’ Needs: A Former HHS Employee
A heartrending article by a former assistant secretary of public affairs and deputy chief of staff at the Department of Health and Human Services, highlights the disconnect between FDA’s requirements for critical drug approval and patients’ need. This is not the only case of its kind where patients and physicians...Read More
When Your Vendor Screws Up: Pfizer and Care Access for Lyme Trial
A couple of weeks back Pfizer announced that it is dropping about 3500 patients recruited to its Phase 3 clinical trial for a vaccine for Lyme disease due to GCP compliance issues related to its “clinical trial site operator”, Care Access. This is not normal; rather this is likely the only incidence of its kind ever reported publicly. Read More
FDA is Out of Touch With Patients’ Needs: A Former HHS Employee
A heartrending article by a former assistant secretary of public affairs and deputy chief of staff at the Department of Health and Human Services, highlights the disconnect between FDA’s requirements for critical drug approval and patients’ need. This is not the only case of its kind where patients and physicians...Read More
When Your Vendor Screws Up: Pfizer and Care Access for Lyme Trial
A couple of weeks back Pfizer announced that it is dropping about 3500 patients recruited to its Phase 3 clinical trial for a vaccine for Lyme disease due to GCP compliance issues related to its “clinical trial site operator”, Care Access. This is not normal; rather this is likely the only incidence of its kind ever reported publicly. Read More
