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FDA to Drop Two-Study Rule for Drug Approvals
The Food and Drug Administration plans to drop its rule requiring two rigorous clinical trials for new drug approvals. FDA leaders found three main problems slowing drugs down.
These are hospital contracting, ethical reviews, and the application process. The FDA chief warned the United States is losing ground to China. China is moving faster in early drug development.
Klear Note — The FDA normally requires two rigorous studies proving drugs work safely before approval. This rule has been standard for decades to protect patients.