Many changes are coming to the US Food and Drug Administration (FDA) by virtue of the passage of the 21st Century Cures Act, the recent confirmation of a new commissioner, and the current administration in Washington, DC, that is inclined toward reducing regulation, a key function of this agency. The clinical community depends on high-quality evidence about medical products, and regulatory oversight is a key mechanism for ensuring collection of that evidence. This point becomes especially apparent when important data to guide care are lacking, as illustrated by the recent example of power morcellators.
Redberg RF, Jacoby AF, Sharfstein JM. Power Morcellators, Postmarketing Surveillance, and the US Food and Drug Administration. JAMA. 2017;318(4):325–326. doi:10.1001/jama.2017.7704
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