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 tobacco regulations.
The Office of the Inspector General (OIG) aims to assess to what extent “FDA requires post-marketing studies and clinical trials for new drug applications.” They are interested in how FDA exchanges the information of drug traceability and safety within the supply chain, as well as the possibility of computerized medical devices in hospitals providing opportunity for security and privacy failures.
For the HHS’ 2016 work plan, click here. To read Brennan’s article, click here. Need help with post-marketing surveillance or managing your supply chain? Contact us.