House panel urges FDA to bar Chinese clinical trial data from drug applications
read at Endpoints ↗RegulatoryNegative
A House spending committee introduced language urging the FDA to prohibit the use of clinical trial data generated in China when reviewing new drug applications.
The proposal reflects concerns about data integrity and national security, and would require drug makers to rely on data from other sources for FDA submissions.
If adopted, the rule could delay development timelines for companies that conduct trials in China and may increase costs, while supporters argue it protects American patients.
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This writeup was produced by pharmadog from original reporting by Endpoints.
Original headline: “House panel calls to ban China data from FDA drug trial applications”
read at Endpoints ↗93 words · retrieved Apr 30
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