Applicant Orientation Meetings

Seize the Opportunity (Part 1)

By Neelu Agrawal

PharmApprove has a long track record of alerting our clients to the potential for an Applicant Orientation Meeting (AOM) – and helping teams strategize and prepare.

Applicant Orientation Meetings (AOMs) are held between the FDA and the Applicant, shortly after the NDA or BLA has been submitted.  AOMs are a crucial opportunity to communicate your argument for approval and engage in an early dialogue with the review division – before key decision makers have been influenced by the concerns of individual reviewers.   

AOMs originated in the Oncology division.  Richard Pazdur, Director of the Oncology Center of Excellence, realized back in 1999 that he “didn’t hear about an application until the review was done . . . but it was very important to hear . . . what is the drug company saying about this application? What is their position?”[1]

AOMs are currently optional, based on the review team’s discretion.  However, they are standard in Oncology and are increasingly being adopted by other divisions, especially for Priority, Breakthrough and expedited review applications.

In our next post, we will go over the basics – including the audience, agenda and presentation content.  And in our final post, we will discuss best practices for preparation.

For more information on how PharmApprove can support your team, please contact info@pharmapprove.com. 

A copy of FDA’s General Advice for AOMs can be provided upon request.