First FDA interactions for an early-stage company
23 Sep 2025
Regulatory Strategy
- When should a company first reach out to FDA?
- When do you hire a full time Regulatory Affairs professional?
- Is applying for and receiving “Break Through” status an important strategy?
- When should a development stage company start a “Design History File”?
- What do you tell FDA if you must make a change to your product after IDE approval?
Industry Expert
