The Pew Charitable Trusts understands the tremendous impact these products have on public health. This project advances policies that will effectively protect consumers from dangerous products and reduce safety risks associated with new innovations in the marketplace. Pew’s current efforts focus on diagnostic tests, dietary supplements, over-the-counter drugs, and regenerative medicine.
The Food and Drug Administration has pledged that after May 31, 2021, the agency will broadly enforce requirements that developers of regenerative medicine products—therapies intended to repair or replace damaged cells, tissues, and organs—follow relevant approval rules for new drugs, medical devices, and biologics. FDA’s increased enforcement comes not a moment too soon: Hundreds of businesses continue to sell unapproved—and unproven—regenerative therapies directly to consumers, leading to patient injuries and deaths.
At a time when most Americans say they have taken dietary supplements, the Food and Drug Administration just does not have the tools to effectively ensure that these products are safe. In a recent survey, a majority of adults echoed this concern: 7 in 10 said they think the agency cannot protect consumers from harmful supplements.
Health care providers rely on a variety of tools to diagnose conditions and guide treatment decisions. Among the most common and widely used are <i>in vitro</i> diagnostics (IVDs), which are clinical tests that analyze samples taken from the human body. Patients may receive—or forgo—medical care based on diagnostic test results, making it critically important that tests are reliable.
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