Part 1: 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, IV)
• FDA Modernization Act (FDAMA) of 1997
• Bioterrorism Act of 2002
• FDA Organization to enforce the laws

Part 2: FDA Pre-IND Meeting

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

Part 3: Regulations and Guidelines for the IND Process

• What is the FDA looking for – CMC, Nonclinical, Clinical 
• How, where, and when to file submissions
• Use of the Common Technical Document (CTD) format
• State regulations and guidelines
• Supporting your IND with clinical trials outside the USA
• Commitments of the IND sponsor

Part 4: FDA Regulatory Drug Development Process and Strategic Considerations

• 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
• Dispute Resolution  

Part 5: FDA End of Phase 2 Meeting

• Critical importance of the End of Phase 2 (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

Part 6: 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

Part 7: Preparation of the NDA/BLA/ANDA Submission

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

Part 8: Review of the Common Technical Document (CTD) Format

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

Part 9: What Happens After the Marketing Dossier is Submitted

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

Part 10: Generics

• How different than a new chemical entity
• Guidances
• Legal Considerations
• Bioequivalence
• Submission Content and Format
• Where to File
• Approval

Part 11: Post-Approval Submissions

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

Part 12: Other Regulatory Topics

• Freedom of Information Act
• Inspection Regulatory Actions
• Drug Master Files
• Form

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