Drug Target Review

NOVEMBER 1, 2023

We often screen using a biochemical assay, but we can conduct cell-based screening as well. For fragment screening, we can screen with biophysical methods, such as thermal shift assays or, you may have heard about Surface Plasmon Resonance (SPR) which is a very sensitive biophysical technique used for fragment screening.

Fragment Screening 96

Fragment Screening Biochemical Assays Small Molecule Biophysical Assays 96

Agency IQ

JUNE 26, 2023

While the pilot has been in development for a while, the move comes as the FDA is looking towards a broader shift in its approach to LDTs. Further, footnote 7 in the document explains: “Examples of such clinical laboratory tests are commonly used and well understood biochemical assays (e.g.,

FDA 40

FDA Laboratories Clinical Trials Science 40

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.” The new draft guidance can be broken into three main parts.

Production 40

Production FDA Therapies Biochemical Assays 40