August 20, 2019 | FDA to Close Public Consultation on ICH M10 Bioanalytical Method Validation

The US Food and Drug Administration (FDA) public consultation of the International Council for Harmonisation (ICH) draft guideline, M10 Bioanalytical Method Validation will close next Monday August 26.

The Draft Guidance, which covers bioanalytical method validation, is aimed at enabling sponsors to improve the quality and consistency of bioanalytical data and support the development of new drugs and biologics through a range of recommendations on “the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples.”

The FDA was among the last of ICH’ Members to hold a public consultation on the guidance, following earlier consultations by peak domestic regulators in Brazil, Europe, Japan, Taiwan, Korea, Japan, China and Switzerland.

The 57-page guidance, which has been in development since Q4 2016, is predicted to move from Draft (Step 2b) to Steps 3 and 4 (Adoption of the Harmonized Guideline) in November 2020 after submissions close Monday August 26th.

ICH Public Consultation Recommendations can be submitted here