ARTICLE SUMMARY:
Arina Consulting founder Allison Kumar offers insights for companies on making the most of FDA’s Pre-Submissions, or Pre-Sub, process.
Last month, Allison was a featured presenter at AcKnowledge Regulatory Strategies’ 2019 Regulatory Alliance Forum in San Diego, CA, where she provided experienced insight into the FDA Pre-Submission (Pre-Sub) process, among other topics. (MedTech Strategist was a Media Sponsor of this event.) Market Pathways caught up with Allison recently to talk about the key elements that device developers need to keep in mind as they prepare for a Pre-Sub, which represent an important, early, foundational interaction with FDA.
