FDA guidance page

U.S. Food and Drug Administration. (2007). FDA guidance page. Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests.

Type

Journal article

Intellectual base

Primary research

Year

2007

Link

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/statistical-guidance-reporting-results-studies-evaluating-diagnostic-tests-guidance-industry-and-fda

Cited by

1 citation across 1 artifact.

Domain-specific

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

Verification

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