This week, the company has reached a major milestone regarding SmartTab's regulatory pathway and upcoming preclinical study, upon successfully filing a Pre-Submission Package for InjectTab™ and receiving acceptance confirmation from the FDA for review. This news comes just in time as the team enters preclinical studies with the InjectTab™ oral biologic capsule.
InjectTab™ is a microneedle capsule with sensors and a microprocessor that confirms ideal positioning of the capsule and deliver life-saving biologic medication through an oral route of administration. Not only does our platform have the potential to deliver medicine less painfully and more effectively to the human body, we can obtain superior compliance and patient outcomes.
"The InjectTab™ FDA Pre-Submission is a major step forward as we enter preclinical studies. Big thank you to our Engineering and Regulatory Affairs team for making this possible."
-Robert Niichel, CEO of SmartTab
The purpose of the Pre-Submission is to build relationships and understanding with the FDA and educate the review team on the novel technology of InjectTab™, including design, testing and development plans that will facilitate FDA review, guide product development and application preparation as the company enters preclinical studies Summer 2022.
SmartTab will work interactively with FDA reviewers during the Pre-Submission process through meeting scheduling, administrative questions, and providing clarification on aspects of the InjectTab™ Pre-Submission documents for reviewers to respond with their best advice. We believe this is a mechanism that will foster collaboration and dialogue with the FDA to advance device development and result in a better quality submissions.
We believe the SmartTab team is on a clear path to complete additional clinical studies, obtain FDA approval and bring InjectTab™ to market by 2024. SmartTab is on a mission to advance care delivery for the 21st century—right here, right now.