The Wall Street JournalThe Wall Street Journal

FDA increasingly halting human trials as companies pursue risky, cutting-edge drugs

By Liz Essley Whyte

10 Jan 2023 · 5 min read

Editor's Note

According to a WSJ review, the agency paused clinical trials for experimental medicines due to biotechs pursuing newer technologies like gene therapies, which promise breakthroughs but present risks.

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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