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...
FDA recommends that partnerships should be used to better monitor medical device performance once released. The article states knee replacements as an example of an area that uses multiple different medical devices, yet the performance information has not been...
After nearly twenty years with the current Good Clinical Practice (GCP) guidelines, ICH is publishing an addendum that will change definitions, principles and responsibilities for the future. These changes include new requirements of compliance and risk, many of which...
The Indiana Medical Device Manufacturers Council is hosting the second of a two-part event on September 10th. The workshop allows participants to hone their skills, while learning more about the background of the industry. This event targets people who are new to the...
