December 2016 – The U.S. Food and Drug Administration (FDA) finalized its guidance intended for institutional review boards (IRBs), investigators, and sponsors engaged in (or responsible for) oversight of human subject research under the Department of Health and Human...
Two weeks ago, the US Food and Drug Administration (FDA) announced the withdrawal of a proposed rule from 2001. The rule would have required the public disclosure of summaries of safety and effectiveness data from pre-market clinical trials of gene therapies and...
According to Zachary Brennan of RAPS, The U.S. Department of Health and Human Services Inspector General will be investigating FDA on post-marketing requirements, supply chain exchanges, hospital medical device oversight, and three additional programs on food and...
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...
With the previous resignation of Commissioner Margaret Hamburg, there has been talk that current deputy commissioner for medical products and tobacco, Robert Califf, may soon be the new US FDA commissioner. Concurrently, the US Senate is working to permanently...
