Marketed Unapproved Drugs – Guidance

GOOD MANUFACTURING PRACTICE (cGMP)
1

Marketed Unapproved Drugs –Compliance Policy Guide

Sec. 440.100
Marketed New Drugs Without Approved NDAs or ANDAs

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf