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