In responding to deficiencies, resubmission responses from applicants to issued complete response letters must be in the form of a "Complete Response Amendment."

• Address all discipline deficiencies in a single amendment.
• Label the Cover Letter, “Complete Response Amendment” and list the disciplines responded to (CHEMISTRY, LABELING, etc).
• Utilize the Regulatory Project Manager (RPM) in the Office of Generic Drugs (OGD) as the primary point of contact for ANDAs.
• Do not contact reviewers, team leaders, division directors and others in management, as this is ineffective and slows OGD down.
  
  Please find details in Section V of FDA's Guidance for Industry: ANDA Submissions— Amendments and Easily Correctable Deficiencies Under GDUFA: http://www.fda.gov/downloads/Drugs/GuidanceCompliance
  RegulatoryInformation/Guidances/UCM404440.pdf