Docs of the Month: Reports Explore Real-World Evidence, Adverse Events, and Telehealth

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ARTICLE SUMMARY:

A look at three notable government reports issued in March: FDA on real-world evidence as a regulatory tool, MedPAC scrutinizes telehealth, and China crunches adverse event numbers.

Docs of the Month is a regular column highlighting key findings from Pathway Document Depot, a running inventory of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.

Many documents issued by government bodies are intended to create or revise public policy (e.g., legislation and regulations), or help implement new policies (e.g., guidance documents). But there is another strand of documents that have a softer goal of informing stakeholders about the outcomes of policies or influencing their perceptions. Reports and white papers from government agencies don’t carry any legal authority but they can be important windows into agency thinking and a source of key datapoints.

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