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Biochemical Assays

Drug Development

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

APRIL 12, 2024

Assays are tests designed to assess various properties (like potency) of chemical or biological samples. The first (pages 1-5) explains what regenerative medicine products are, provides an overview of what “risk management” means, and cites the requirements that drug developers must satisfy per the U.S.

Production

Production FDA Therapies Biochemical Assays

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

Further, footnote 7 in the document explains: “Examples of such clinical laboratory tests are commonly used and well understood biochemical assays (e.g., The FDA expects that CDx will be approved with a drug, but that’s not always feasible.

FDA

FDA Laboratories Clinical Trials Science

Drug Discovery Digest

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

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

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