FDA COMPLIANCE POLICY GUIDE Sec. 440.100 Marketed New Drugs Without Approved NDAs (CPG 7132c.02)
Title:
FDA COMPLIANCE POLICY GUIDE Sec. 440.100 Marketed New Drugs Without Approved NDAs (CPG 7132c.02)
Origin/Publisher:
Office of Regulatory Affairs, FDA
Document Type:
Compliance Policy Guide
Content:
Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.