FDAnews
www.fdanews.com/articles/164712-drugmakers-ask-fda-for-clarification-on-analytical-validation-methods-guidance

Drugmakers Ask FDA for Clarification on Analytical Validation Methods Guidance

May 23, 2014

Drugmakers are asking the FDA to create separate submission requirements for NDAs, ANDAs and BLAs to demonstrate analytical procedures and methods-validation data is adequate to support the drug and biologic products.
Drug Industry Daily