Tag Archives: CDER

FDA Issues New Draft Guidance on Class Labeling of Companion Diagnostics for Oncology Therapeutic Products

On December 6, FDA Commissioner Gottlieb announced in a press release the availability of a new draft guidance entitled, “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products” (Draft Guidance). The agency also published the Draft Guidance announcement in the December 7 Federal Register. FDA issued … Continue Reading

FDA Issues Draft Guidances Outlining Digital Health and Decision Support Software Regulatory Approaches

FDA has described its evolving approach to regulating digital health and decision support software in two new draft guidance documents:  Clinical and Patient Decision Support Software and Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.  These draft guidances announce the agency’s initial interpretation of the health software … Continue Reading
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