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District Court Interprets EKRA

FDA Law Blog

Note that while EKRA was passed as part of a bill to combat the opioid crisis, its definition of “laboratory” applies to lab activities far beyond those involving opioid or other drug testing. In particular, the employee exemption, relevant to the S&G Labs Haw., S&G Labs Haw., 18 U.S.C. § 24(b) (emphasis added).

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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance. Medical information about a patient.

Clinic 52
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District Court Interprets EKRA

FDA Law Blog

Note that while EKRA was passed as part of a bill to combat the opioid crisis, its definition of “laboratory” applies to lab activities far beyond those involving opioid or other drug testing. In particular, the employee exemption, relevant to the S&G Labs Haw., S&G Labs Haw., 18 U.S.C. § 24(b) (emphasis added).