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Summary

Description

Figure 4. Anticipated response to the proposed rule. Respondents were asked how they think their laboratories would respond to the new regulatory requirements regarding their existing LDTs if the FDA adopts the proposed rule.

Source

Smith, Leslie; Carricaburu, Lisa A.; Genzen, Jonathan R. (2024). "The US FDA’s proposed rule on laboratory-developed tests: Impacts on clinical laboratory testing". Practical Laboratory Medicine In press: e00407. doi:10.1016/j.plabm.2024.e00407. 

Date

2024

Author

Smith, Leslie; Carricaburu, Lisa A.; Genzen, Jonathan R.

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