BEBAC  Ing. Helmut Schütz

US – FDA

Draft Guidance for Industry on Bioanalytical Method Validation

On 13 Sep 2013 FDA’s Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine (CVM) published the drafted guidance for a 90-day public consultation period (i.e., until 12 December 2013).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Bioanalytical Method Validation.” The draft guidance is intended to provide recommendations regarding analytical method development and validation for the measurement of drugs and/or metabolites, therapeutic biologics, and biomarkers for sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) for therapeutic biologics regulated by the Center for Drug Evaluation and Research. This draft guidance may apply to some studies related to the veterinary drug approval process (Investigational New Animal Drugs (INADs), New Animal Drug Applications (NADAs), and Abbreviated New Animal Drug Applications (ANADAs)) regulated by the Center for Veterinary Medicine.

This guidance provides general recommendations for bioanalytical method validation. The recommendations can be modified depending on the specific type of analytical method used.

Originally issued in 2001, this guidance has been revised to reflect advances in science and technology related to validating bioanalytical methods. The guidance is being reissued in draft to enable public review and comment before it is finalized.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit electronic comments on the draft guidance by December 12, 2013 to www.regulations.gov.
See also “Tips for Submitting Effective Comments”.

Update

On 21 May 2018 the FDA published the final guidance.

This final guidance incorporates public comments to the revised draft published in 2013 and provides recommendations for the development, validation, and in-study use of bioanalytical methods. The recommendations can be modified with justification, depending on the specific type of bioanalytical method. This guidance reflects advances in science and technology related to validating bioanalytical methods.