Biochemical Assays, Clinical Development and Trials

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Biochemical Assays

Clinical Development

Trials

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., However, CDx development and authorization is extremely challenging. The FDA expects that CDx will be approved with a drug, but that’s not always feasible.

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Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input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

Assays are tests designed to assess various properties (like potency) of chemical or biological samples. Others seem to be taken aback by this new approach, expressing concerns as to what these changes might mean for sponsors prepping to move their assets into early-stage clinical trials, and more broadly for all of industry moving forward.

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Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

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