FDA Guidance for Industry: M5 Data Elements and Standards for Drug Dictionaries
Title:
FDA Guidance for Industry: M5 Data Elements and Standards for Drug
Dictionaries
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073307.pdf
Content:
It is desirable for regulators and pharmaceutical industry to engage in an intensive information exchange during the drug development phase, the drug evaluation and approval phase and the post-authorization phase