New US FDA draft guidance on bioanalytical method validation versus current FDA and EMA guidelines: chromatographic methods and ISR

“Seemingly more freedom and responsibility are given to the skilled and experienced bioanalyst to design and conduct appropriate protocols for all aspects of method validation.” The long awaited US FDA draft guidance on bioanalytical method validation (BMV) has been published on 12 September 2013 [101] and is open for comments and suggestions within 90 days of publication. After finalization, it will replace the currently effective FDA BMV guidance of 2001 (referred to as the ‘FDA 2001’ in this article) [102]. Bioanalysts worldwide are discussing the draft guidance, and pharmaceutical companies and CROs are to submit their comments to the FDA....