More webinars coming soon . . .
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
What do the recent FDA Guidances mean for historical OPDP/DDMAC enforcement and for your company’s risk profile?
Join OSR’s expert, in depth, webinar training program addressing the questions around the FDA Medical Product Communications That Are Consistent With the FDA-Required Labeling Consistent with FDA-Required Label and Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities Guidance Documents, substantial evidence, and clinical trial design. This webinar will specifically focus on the following:
· Clinical trial design: multiplicity and multiple endpoints, inclusion and exclusion criteria, valid comparators, blinding and randomization, prospective specification, primary, secondary and exploratory endpoints, and study power
· Assessment of enforcement letters on promotional material making claims using the substantial evidence definition
· Relevance of enforcement letters issued before FDA’s Medical Product Communications That Are Consistent With the FDA-Required Labeling guidance (CFL)
· Case studies - using data in promotion applying the FDA Medical Product Communications That Are Consistent With the FDA-Required Labeling (CFL) guidance in contrast to the substantial evidence standard historically stated in enforcement letters
· Case studies - using data in health care economic information applying FDA’s Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities guidance.