Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA

Personnel in the pharmaceutical, biotechnology and generic drug industry who are involved in preparing FDA submissions (INDs, NDAs, BLAs, ANDAs, post-approval supplements) or who will need to interact with FDA staff, including Project Managers, Regulatory Affairs, Clinical, Nonclinical, Manufacturing, and Quality personnel.

Course Objectives

• Understand the importance and underlying principles of the FDA drug development process from Phase 1 IND through market approval
• Learn how to create adequate and appropriate FDA submissions throughout the drug development process covering CMC, Nonclinical and Clinical areas
• Learn how to effectively prepare for, and communicate during, meetings with the FDA
• Understand the seriousness that the FDA takes its responsibilities

Course Description

This course will give the participants the background and history of the Food and Drug Administration (FDA) as a basis for the strategic planning of submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements. Each item of these submissions will be individualized, analyzed, and discussed in conjunction with their importance in relation to FDA regulations and guidances. Each item will be detailed as to how to best present the data for successful FDA approvals.

The course content will include preparing for FDA meetings and discuss all the nuances of pharmaceutical industry interaction with the FDA. Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be covered. The Common Technical Document (CTD) formatting will be discussed.

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COURSE AGENDA

DAY ONE

Basis for FDA’s Authority to Regulate Drugs and Biologics

• Pure Food and Drug Act of 1906
• Federal Food, Drug and Cosmetics Act of 1938
• FD&C Act Amendments of 1962
• Prescription Drug User Fee Act (PDUFA I, II, III)
• FDA Modernization Act (FDAMA) of 1997
• Bioterrorism Act of 2002
• FDA Organization to enforce the laws

FDA Regulatory Drug Development Process

• From pre-IND through market approval
• Different types of INDs
• FDA expectations at each stage of drug development
• Role of the IND and NDA/BLA submissions
• Accelerated FDA review processes

FDA Pre-IND Meeting

• Why have a pre-IND meeting with the FDA
• Identifying the CMC, Nonclinical and Clinical issues
• Scheduling the meeting with the FDA
• Preparing the briefing document
• Preparing for the meeting with the FDA

Preparation of the IND Submission (and Amendments) – Phases 1 and 2

• What is the FDA looking for – CMC, Nonclinical, Clinical
• How, where, and when to file submissions
• Use of the Common Technical Document (CTD) format at Phases 1 and 2
• Commitments of the IND sponsor
• Reporting clinical trial Adverse Events

FDA End-of-Phase 2 (EOP2) Meeting

• Critical importance of the EOP2 meeting with the FDA
• Identifying the CMC, Nonclinical and Clinical issues
• Preparing the briefing document for the meeting
• Scheduling the meeting with the FDA
• Preparing for the meeting with the FDA

Preparation of the IND Submission – Phase 3

• What is the FDA looking for – CMC, Nonclinical, Clinical
• How, where, and when to file submissions
• Use of the Common Technical Document (CTD) format at Phase 3
• Commitments of the IND sponsor
• Reporting clinical trial Adverse Events

DAY TWO

FDA Pre-NDA/BLA Meeting

• Why have a pre-NDA/BLA meeting with the FDA
• Identifying the CMC, Nonclinical and Clinical issues
• Identifying the administrative issues for this filing
• Scheduling the meeting with the FDA
• Preparing for the meeting with the FDA

Preparation of the NDA/BLA/ANDA Submission

• What is the FDA looking for – CMC, Nonclinical, Clinical
• FDA guidances provided
• How, where, and when to file submissions

Review of the Common Technical Document (CTD) Format

• Background on ICH and the CTD
• The 5 CTD modules
• FDA and ICH guidances on using the CTD format
• The eCTD specification

What Happens After the Marketing Dossier is Submitted

• Refusal to file
• FDA review process for NDA/BLA/ANDA submissions
• Advisory Committee meetings
• Pre-approval inspections
• Label approvals
• Complete review letters
• Approval letters

Post-Approval Submissions

• Identify requirements for NDA/BLA amendments
• Process change control and product comparability
• Post-approval commitments (Phase 4 studies)
• Field Alerts and Biologic Deviation Reports
• Annual Reports

Rich FDA Resources

• Understanding the Freedom of Information Act (FOIA)
• FDA guidance documents available from FDA website
• ICH guidance documents available form ICH website