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Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarketi...
Federal Register notice: FDA revokes an Emergency Use Authorization issued to InBios International for the ZIKV Detect 2.0 IgM Capture ELISA test.
Federal Register notice: FDA releases an annual report on agency advisory committees that held closed meetings during fiscal year 2018.
In an 8/7 letter to physicians, FDA says updates to device labeling and clinical trial informed consent documents are coming because of ongoing concer...
FDA funds a meeting to launch a new rare disease data analytics platform.
FDA clears a NinePoint Medical for the NvisionVLE Imaging System for use in the pancreas and bile duct.
The Government Accountability Office suggests ways in which FDA could address factors that restrict generic drug first review cycle approvals.