Launching an Accelerated Approval Product - What you need to know NOW!

Join OSR’s expert, in-depth, webinar training program which will address key topics related to advertising and promotion for accelerated approval products. This webinar will address the following learning objectives:

  • What are accelerated approval products and what are the FDA/OPDP requirements?
  • We are planning to submit our materials to FDA/OPDP prior to the accelerated product approval – we need direction on when and how to do this. What do we need to do with the files and how do we package the submission?
  • Should I expect comments from FDA/OPDP on our accelerated approval promotional materials submissions – or do we need to specifically request advisory comments?
  • We submitted our accelerated approval promotional materials prior to FDA approval of our product, but the labeling has changed from the draft labeling we developed our promotional materials from – what do we do?
  • If we seek FDA/OPDP advisory comments for our launch materials, must we still submit the first 120 days accelerated approval materials prior to FDA product approval?
  • Help – we just found out that FDA plans to advance the action date for our accelerated approval product – what do we do now?
  • What are the key dates we need to know?

Interactive Case Study: What do you do when you have an upcoming product approval with two (2) indications – one is accelerated approval and the other is a full approval? Join the discussion on this topic, including participant polling questions.

Presented by Nicol George, Pharm.D., R.Ph., Executive Director, Regulatory & Medical Review Services - OneSource Regulatory

$199 per Person

Reach out to info@OneSourceRegulatory.com for group rates (on-site & remote)!

Monday, January 13th, 2020

9AM Pacific/12NOON Eastern

(1.5 Hours)