If we as an industry learn anything from battling the COVID-19 pandemic, David Burrow, PharmD, JD, director of the Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation […]
Developing new formulations and therapeutic targets for approved drugs may help treat cancer and other diseases. This is the concept behind the South Dakota State University-led Center for Drug, Disease, […]
Regulators for the U.S. Food and Drug Administration (FDA) “like to see a focus on corrective and preventive actions” (CAPAs) after they issue a Form 483 to managers of a […]
Scientists from St. Jude Children’s Research Hospital have proposed a new method for designing Phase II clinical trials and created a corresponding software to implement the approach. The work was […]
Although COVID-19 affects men and women differently, most current clinical studies of SARS-CoV-2 and COVID-19 make no mention of sex and gender. Indeed, only a fraction (4%) of such studies […]