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The FDA announced late last week that it is requiring evaluation of all prevention studies involving Celebrex and Bextra to ensure that adequate precautions are implemented in the studies and instructing institutional review boards to reevaluate them in the wake of recent evidence that the compounds may cause increased cardiac risk.
On June 8 the FDA released a warning letter to biotechnology firm Celsion on May 7 that details violations discovered during the Phase I and Phase II trials of its Prolieve Thermodilatation system.
The FDA has accused an institutional review board (IRB) associated with Wright Medical of failing to report adverse events and using unsubstantiated clinical information in its premarket approval (PMA) applications.
The FDA has cited a California hospital’s institutional review board (IRB) for inadequately reviewing clinical device trials and failing to provide accurate documentation about its membership and oversight process.
California-based devicemaker Staar Surgical has been taken to task by the FDA for failing to obtain approval before initiating a clinical study that the agency claimed was inadequately administered and supervised.
A New York institutional review board (IRB) may be disqualified if it does not correct several violations cited during a recent FDA inspection, placing all current device research under its oversight in jeopardy.