Sentence examples for fda validation from inspiring English sources

This method has been validated to meet FDA validation guidelines.

Nearly 300 supplemental indication applications relating to approved prescription drugs have been approved in the past decade, providing FDA validation for a wide range of uses beyond the drugs' original indications.

What will validation validate?

For qualitative validation, we used the FDA-approved OraQuick In-Home HIV test and the OraQuick ADVANCE Rapid HIV-1/2 antibody test (OraSure Technologies, Inc., PA, USA).

In short the developed and validated GCMS method for diclofenac satisfy all the criteria for US-FDA's "Guidance for Industry Bioanalytical Method Validation:" [34] The method is very reliable and robust for quantitative determination of diclofenac in human plasma.

FDA-cleared CIDTs undergo various levels of validation before they are made available for purchase in the United States, but postmarketing evaluations are generally not required (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm407296.htm).

The method conforms with FDA-Guidelines 'Guidance for Industry – Bioanalytical Method Validation (May 2001)', which implies proof of reproducibility within a given error range.

The method has been proven to be in conformance with FDA-Guideline "Guidance for Industry - Bioanalytical Method Validation (May 2001"), which implies proof of reproducibility within a given error range.

The CAP has advised that rigorous validation is required for offering a non-FDA-approved HPV test in certified high-complexity testing laboratories under CLIA 88 [ 12, 13].

The Guidance for Industry entitled "Analytical Procedures and Methods Validation for Drugs and Biologics" was published by FDA on 27 July 2015 (Food and Drug Adminstration, Guidance for Industry 2015).

As commercially available, Food and Drug Administration (FDA -cleared AFDA -clearede not vAFPdassaysor these fluid types, lareratories must complete additionot validatedn studies to comply with regulatory requirements for body fluid theseng.