FDA guidance page

U.S. Food and Drug Administration / International Council for Harmonisation. (2022). FDA guidance page. M10 Bioanalytical Method Validation and Study Sample Analysis.

Type

Report

Intellectual base

Grey literature

Year

2022

Link

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m10-bioanalytical-method-validation-and-study-sample-analysis

Cited by

1 citation across 1 artifact.

Domain-specific

• ELISA
  • FDA guidance treats analytical validation and diagnostic-performance evaluation as distinct evidentiary burdens.

Verification

This reference passed the adversarial substantiation pipeline: it was checked to exist and to support the claim it is attached to. See how references were verified.

Links previously used in the corpus

Before the registry existed this work was also linked 1 other way.

• https://www.fda.gov/media/162903/download ×1

Registry ID ref:c85bd13d0c98 · see in the full table