All regulatory communications have data.
Successful communications have a story.
Work with 3D to get your story straight from the start.
Seize the specific opportunities of an AOM interaction.
Gain insights from FDA to understand potential review issues.
Discuss novel elements of your clinical program.
Be ready with the right messages.
That’s where 3D comes in. 3D helps you
-
Set your meeting strategy and create content before you submit your data.
-
Proactively address and mitigate potential FDA review issues.
-
Capture feedback and insights from AOM to inform your ADCOM strategy.
We work with you maximize your AOM, so you’re set up for success throughout the regulatory process.
“Partnering with 3D was integral to how our team prepared for our AOM. We maximized this early interaction to not only share our data—but to tell our story around potential FDA issues. This put us a step ahead for ADCOM prep and gave us another chance to drive our messages.”
Joe Stauffer, MD
Chief Medical Advisor, Seikagaku
CEO and Founder, Delta Life Sciences
AOM = Application Orientation Meeting
Our Latest Thinking
- Post-Marketing Plans: An Often-Overlooked Component of FDA Advisory Committee Meeting Discussions
- CDER Expedited Pathways: Why Do Some Drugs Get Approved Quicker than Others?
- Anticipating Common Questions During an Rx-to-OTC Switch
Our proven process 3D ACT® is not magic. It's better.
Learn Why