The Institute of Medicine has issued a report to Congress criticizing the FDA?s drug approval system.
The Institute of Medicine has issued a report to Congress criticizing the FDA’s drug approval system. The report offers 25 recommendations for improving drug safety. Among them is one calling for restricting the distribution of certain drugs to certain facilities, pharmacists, or physicians with special training or experience. Also, IOM recommends adding a symbol on newly approved drugs to alert consumers that long-term safety data might not be available. In response, the FDA said it would take the recommendations under advisement, but noted that many of the suggestions are already being put in place. To review the report, “The future of drug safety: Action steps for Congress,” go to http://www.iom.edu/CMS/3793/26341/37329.aspx.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.