Federal Register Notice: FDA is making available a draft guidance for industry entitled Bioanalytical Method Validation. It is intended to provide recommendations on analytical method development and validation for measuring drugs and/or metabolites, therapeutic biologics, and biomarkers for sponsors of INDs, NDAs, ANDAs, and BLAs for therapeutic biologics regulated by CDER. The draft guidance may also apply to some studies related to the veterinary drug approval process INADs, NADAs, ANADAs regulated by CVM. The document is a revision of 2001 guidance. To download this guidance, click here. To view this notice, click here.