The drugs and devices have been on the market for years. But FDA-ordered studies still aren’t done. - Takeaways - MDSpire
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The drugs and devices have been on the market for years. But FDA-ordered studies still aren’t done.

“Doctors rely on this evidence, patients rely on this evidence, and if that evidence is not there, it’s going to lead to a lot of uncertainty."

  • By

  • David Hilzenrath

  • September 22, 2026

  • 14 min

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  • 1

    The FDA approved the drug Tavneos despite limited safety data, requiring a postmarket study that is currently delayed.

  • 2

    As of last fall, only 21 of the planned 300 patients had been enrolled in the Tavneos postmarket study.

  • 3

    The FDA has identified numerous cases of liver damage possibly linked to Tavneos, which the postmarket study was intended to evaluate.

  • 4

    Nearly 600 postmarket studies are behind schedule, affecting almost 350 products, according to an FDA database.

  • 5

    Delays in postmarket studies can lead to uncertainty regarding the risks and benefits of drugs and devices for patients and healthcare providers.

Original Source(s)

The drugs and devices have been on the market for years. But FDA-ordered studies still aren’t done.

  • by David Hilzenrath

  • September 22, 2026

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