Webinars
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)