Investigation raises concerns about poor FDA oversight of clinicaltrials bmj_latest sciencemagazine
COVID-19 vaccines and drugs were developed at"warp speed" and now experts are concerned about the US Food and Drug Administration's inadequate surveillance of clinical trial sites, reports an investigation published byRegulatory documents show that only nine out of 153 Pfizer trial sites were subject to FDA inspection prior to licensing its COVID-19 mRNA vaccine.
Experts have criticized the FDA's oversight of clinical trials, describing it as"grossly inadequate." They say the problem, which predated COVID-19, is not limited to a lack of inspections, but also includes failing to proactively notify the public or The FDA oversees clinical research of FDA-regulated drugs and devices in the US and abroad, if the product is intended for the US market. It conducts routine visits for trials, reviews records of those sites or the institutional review boards that oversee trials locally and follows up on complaints of violations. The FDA does not have a target for the proportion of trial sites it inspects.
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