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

Does it exist? Not checked yet. This entry carries no identifier to resolve. It was extracted from the citation as written in the article, normalized, and deduplicated against the rest of the registry.

Does it back the claim? Not recorded. The single citation of this work carries no recorded support check.

Support is checked per citation rather than per work — the same source can be cited soundly in one article and wrongly in another. Per-citation recording began recently, so a citation with no recorded check is a gap in the record rather than evidence it went unchecked.

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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