The FDA is pausing studies of experimental drugs more often than it used to, a Wall Street Journal review found
Agency places more holds on trials to protect patients, ensure studies are designed properly, Wall Street Journal review findsPhoto:The Food and Drug Administration is pressing pause on drug-company testing of experimental medicines more often, a side effect of the industry’s move into promising but less-proven technologies.
The agency, which must sign off before companies can begin testing an experimental drug in people, has long used its authority to place holds on studies due to safety concerns. As biotechs pursue more cutting-edge cell and gene therapies, the FDA has been issuing more suspensions than it had, according to a Wall Street Journal review of FDA data on clinical holds, some of which was obtained through a Freedom of Information Act request.
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