Tag: regulatory affairs
How statistical paradoxes mislead drug safety decisions—and why AI may help
Statistical reasoning errors in drug safety evaluation—including the prosecutor's fallacy and Simpson's paradox—systematically distort causality judgments and remain inadequately audited…
FDA’s Pazdur Calls for Agency Restructuring Amid China Competition and Internal Upheaval
FDA's Rick Pazdur calls for fundamental agency restructuring following internal disruption, citing China competition as key driver for reform. Speaking…
FDA Official Who Questioned COVID Vaccines and Antidepressants Exits Amid Regulatory Shifts
A senior FDA official known for questioning COVID-19 vaccine safety profiles and antidepressant efficacy claims has departed the agency, highlighting…
Submit Your Paper to GMJ
No APC until January 2027.