FDA Guidance for Industry: Submitting Marketing Applications According to the ICH-CTD Format — General Considerations
Title:
FDA Guidance for Industry: Submitting Marketing Applications
According to the ICH-CTD Format — General Considerations
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073308.pdf
Content:
This guidance document is intended to describe how to organize new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biological license applications (BLAs) based on the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on the CTD.