Preparing for Meetings with the Food and Drug Administration (FDA)
So really, how do you prepare for meetings with the FDA? They can be quite intimidating, especially for new companies developing a relationship with the FDA for the first time. Who knows what they need to hear? Who knows what they will ask? Do we wing it or do we prepare? Can we prepare? How would we prepare?
Here’s what to do… PREP PREP PREP / PRACTICE PRACTICE PRACTICE!
First, think about the purpose of the meeting . . . what questions do you REALLY NEED addressed? Do we need a face-to-face meeting? Is a teleconference sufficient? (Face to face is ideal, but sometimes a teleconference is all you will get.) What is the ultimate goal of the meeting? What is the desired outcome?
If you can’t answer the above, you’re not ready for a meeting with the FDA. SO head back to the lab, or the clinic, and generate some more data until you’re ready!
If you can answer the above, now it’s time to PREPARE! I know, daunting task isn’t it?!
Once key issues and negotiation points have been determined (much of which is outlined in the Meeting Package sent to the Agency 4 weeks prior to the meeting):
- Review relevant guidance documents and regulations. (Bring them with you for reference!)
- Know your Meeting Package so you can refer to it as needed during the meeting.
- Familiarize yourself with any Regulatory history of related products/issues.
- Be aware of the current Regulatory playing field . . . are there similar products on the market and/or being developed simultaneously?
- Prepare responses for potential questions posed by the FDA.
Logistics (May seem obvious, but you’d be surprised!):
- Assure your team’s travel plans are confirmed and known by all well in advance; the last thing you want is to be late (You’ll end up looking like the 2nd girl above!).
- Make note of the FDA meeting time on your phone, in your notebook, on your kid’s forehead, and on the back of your boss’s shirt (laugh now please). Screw up on the time and you’d be better off crawling into a hole and hiding . . . forever.
- Plan/schedule formal rehearsal times with your team!
During the Meeting:
- Assure the potential speakers from your team know they are on the agenda!
- Choose team members who are relevant to the topics being discussed.
- Use consultants only if needed.
- Assure to have a designated note taker.
- Prior to the meeting ending, summarize/outline key points, agreements, and action plans to assure everyone is on the same page.
- Collect business cards / Distribute business cards.
- Introduce new data that the FDA hasn’t been made aware of in the Meeting Package (they want to be fully prepared for the discussions as well).
- Argue over guidelines or regulations. (You’ll get you wrist slapped with a wet noodle!)
- Come unprepared.
- Ask open ended questions. (Refer back to newsletter, Issue #2 for advice on asking questions!)
- Present. Use the time for discussions.
- Be late! (Duh, sorry, I wanted one more bullet.)
After the Meeting:
- Meet to debrief and write meeting minutes ASAP from notes while fresh in mind.
- Review minutes (from FDA) carefully to assure there are no misunderstandings or miscommunications.
*Remember that the FDA’s minutes are the Official meeting minutes.*
Face-to-face interaction with the FDA is important. Build that relationship. Stay in communication. Open and frequent communication has been proven to have a high impact on a successful review process.
When you arrive at the FDA, who do you want to be? “Miss Cheery” . . . the cool, calm and collected woman with a smile on her face holding the gifts, or “Miss Stress Ball” . . . the panicked, stressed woman ripping her hair out holding the gifts (scroll up if you need a reminder)?! It’s YOUR choice.
Remember . . . we (sponsor company and FDA) all have a common goal . . . efficient, cost-effective product development to ultimately bring safe and effective treatments and diagnostics to the market! Rah Rah, Go Team, GO!
- Get the CRITICAL discussions and questions taken care of first, in case meeting time runs out.
- Don’t force a decision to be made during a meeting if the FDA isn’t ready.
- Don’t make the meeting a time to present . . . that’s what the meeting package is for. BUT . . . have some slides prepared for support/critical topics if they may aide the discussion.
- Know who the FDA meeting attendees will be; study their backgrounds; know who reports to whom and who the key decision makers are. (Perhaps drop him/her a $100 bill while you’re there. Kidding. Seriously kidding!)