Newsletter - March 28, 2024
GAO Evaluated Limitations of the FDA’s GCP Audits
A survey by the General Accountability Office (GAO) reported many interesting facts about the state of clinical trial audits by the FDA inspectors. The purpose of the GAO survey was to identify deficiencies in the FDA audits for compliance with Good Clinical Practices (GCP), but in the process, it reports several surprising...Read More
How Good Are New Drugs Compared to Previous Treatments?
A question as old as the modern drug industry is about the true benefit provided by new treatments. This is an important argument to justify the high cost of newly approved drugs compared to those available in the prior days and years. A study by researchers in Europe raises some interesting questions about the added...Read More
GAO Evaluated Limitations of the FDA’s GCP Audits
A survey by the General Accountability Office (GAO) reported many interesting facts about the state of clinical trial audits by the FDA inspectors. The purpose of the GAO survey was to identify deficiencies in the FDA audits for compliance with Good Clinical Practices (GCP), but in the process, it reports several surprising...Read More
How Good Are New Drugs Compared to Previous Treatments?
A question as old as the modern drug industry is about the true benefit provided by new treatments. This is an important argument to justify the high cost of newly approved drugs compared to those available in the prior days and years. A study by researchers in Europe raises some interesting questions about the added...Read More
