Preparation for a productive FDA Pre-Sub interaction: meeting agenda development, question framing, supporting documentation review, and debrief support after FDA's written response arrives. Reduces the risk of a Pre-Sub that generates more questions than answers.
Preparation for a productive FDA Pre-Sub interaction: meeting agenda development, question framing, supporting documentation review, and debrief support after FDA's written response arrives. Reduces the risk of a Pre-Sub that generates more questions than answers.