Day 1 (8:00 AM - 4:00 PM)

Registration: (8:00 a.m. - 8:30 a.m.)

8:30 – 10:30 AM: Session 1: Kinds of FDA Meetings: Understanding FDA Meetings
  • Types of meetings: Type A, B, and C, breakthrough, biosimilar, medical device meetings
  • Meetings at different stages of development: pre-IND, End-of-Phase 2, Pre-IDE, Pre-NDA, pre-PMA, etc.
  • Differences and similarities in meetings for drugs, devices and biologics
  • FDA criteria for granting or refusing a meeting
  • Criteria for In-Person and over-the-phone meetings

10:30 – 10:45 AM: Break

10:45 – 12:15 PM: Session 2: Deciding When to Meet FDA
  • The “Pre-“ meetings: Pre-IND, pre-NDA, pre-PMA, Pre-Phase 3
  • Creating the rationale for a FDA meeting: Pro and con analysis
  • Potential issues for FDA discussion
  • Evaluating available answers
  • Timing the FDA meeting: When is the best time?

12:15 – 1:15 PM: Lunch

1:15 – 2:45 PM: Session 3: Strategy for an FDA Meeting
  • Collecting available information
  • Gap Analysis
  • Listing potential questions
  • Potential solutions and their FDA acceptability evaluation
  • To have or not to have a meeting with FDA

​2:45 – 3:00 PM: Break

3:00 – 4:00 PM: Session 4: Process for Requesting an FDA meeting
  • Making a request that never fails
  • Identifying the contact Division and persons at FDA
  • The two-step process for a meeting request
  • Identifying sponsor team members and FDA experts
  • Identifying information to be included and avoided
  • Division specific meeting grant criteria: Drugs, biologics and medical devices
Day 2 (8:30 AM - 3:30 PM)

8:30 – 10:00 AM: Session 5: Meeting Information Package
  • Meeting package that never fails
  • What to include, last minute changes
  • Format for the meeting information package
  • Regulatory requirements for content
  • Scope of the meeting information package
  • Printing, publishing and delivering issues
  • Class exercise: Creating a meeting information package

10:00 – 10:15 AM: Break

10:15 – 12:00 Noon: Session 6: Logistics of an FDA Meeting
  • Pre-meeting preparatory activities
  • Reviewing preliminary comments from FDA
  • Meeting presentations
  • Role of team leaders and other members
  • Security processes at FDA and other logistical issues
  • In-person and remote meetings

12:00 – 12:45 PM: Lunch

12:45 – 2:00 PM: Session 7: Conduct of an FDA Meeting: Mock Meeting
  • Class exercise: Mock FDA meeting to highlight the dos and don’ts of an FDA meeting
  • Meeting minutes
  • Follow-up to an FDA meeting

2:00 – 2:15 PM: Break

2:15 – 3:30 PM: Session 8: Special Considerations for Special meetings

  • Periodic meetings: Pre-IND/IDE, End-of-Phase 2, Pre-NDA meetings
  • Type A urgent issue meetings
  • Type C miscellaneous meetings
  • Breakthrough meetings
  • Dispute resolution meetings
  • RFD meetings
  • Biosimilar meetings
  • Pre-sub meetings
  • Animal Rule meetings
  • Advisory Committee meetings