According to Zachary Brennan’s article on RAPS, an Indian active pharmaceutical ingredient (API) manufacturer, Megafine, was banned from FDA after a 483 inspection. Other regulators around the world have approved the company; however that may change soon. The notes...
A final rule published by the Centers for Medicare and Medicaid Services (CMS) requires drug manufactures, including contract manufacturing organizations (CMOs) and group purchasing organizations (GPOs) to report annual payments to physicians or investment interests...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
