We have seen development teams invest months preparing for Scientific Advice with EMA, FDA, MHRA or Swissmedic, only to leave with less clarity than expected.
In many cases, the issue isn’t the advice received. It’s how the questions and applicant positions were framed.
Common pitfalls include:
- Questions that are too broad, leading to high-level responses
- Asking regulators to validate a strategy instead of seeking advice on specific decision points
- Providing insufficient context or failing to present alternative options
- Not clearly defining the development challenge that needs to be resolved
Well-prepared questions enable focused, actionable feedback and can help avoid costly delays later in development.
In our experience, the success of a Scientific Advice meeting is often determined long before the meeting takes place.
Planning a Scientific Advice meeting?
The quality of the feedback you receive is often determined before the meeting starts.
Contact info@starodub.nl to discuss your briefing package and ensure your questions are positioned to support informed development decisions.
In the meantime, we’d be interested to hear your perspective:
What has been your biggest lesson learned from a Scientific Advice interaction?
Share your experience in the comments.
