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Wire · regulatory

FDA-ordered studies of many drugs, devices on the market are not done

Published

17 September 2026

Topic

regulatory

◆ Sectors

Health: Drug Discovery

◆ Geography

United States

◆ Source

Read at washingtonpost.com →

◆ Verified

Fusion42 · 17 September 2026 · Fusion42 review

The FDA has approved drugs with limited pre-market safety data contingent on postmarket studies that are frequently delayed, leaving risks and benefits unclear for patients and doctors. Policy changes reducing preapproval testing increase reliance on these delayed studies, raising concerns about patient safety and financial waste.

This Wire brief sits within Fusion42's coverage of Health: Drug Discovery.

◆ ◆ The Wire takeaway

You face rising risk from FDA approvals that skip extensive safety testing pre-market, relying on postmarket data that often doesn’t arrive. Prepare to manage liability and patient trust while seeking alternative proof of safety.

◆ Coverage

1 source · 17 Sep 2026

◆ Related on Wire

◆ Topics

Health: Drug Discoveryfdadrug-approvalpostmarket-studiespatient-safetyregulatory-delay