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Close up of a horseshoe crab's back in front of the ocean.

PDA Letter

Acceptance of the limulus amoebocyte lysate (LAL) test by the U.S. FDA required 15 years of side-by-side LAL and rabbit pyrogen testing to establish safety and efficacy of LAL as an endotoxin test. As alternative methods to LAL are being introduced to the market, what is the extent of the testing on real-world samples and how do the results compare across the range of critical characteristics, including specificity?

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