Biochemical Assays, Clinical Development and Regulations

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Biochemical Assays

Clinical Development

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Analysis Life Sciences Thank You Amid broader shift on LDT policy, FDA unveils pilot program for cancer drug-linked tests and diagnostics

Agency IQ

JUNE 26, 2023

Because CDx are diagnostic devices, they are not considered part of a combination product but are regulated separately as medical devices. Further, footnote 7 in the document explains: “Examples of such clinical laboratory tests are commonly used and well understood biochemical assays (e.g.,

FDA

FDA Clinical Trials Laboratories Science

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

APRIL 12, 2024

BY RACHEL COE, MSC | APR 11, 2024 1:06 PM CDT Regulatory background: Product potency and assays As defined in statute , the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.”

Production

Production FDA Therapies Biochemical Assays

Drug Discovery Digest

Analysis Life Sciences Thank You Amid broader shift on LDT policy, FDA unveils pilot program for cancer drug-linked tests and diagnostics

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

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