There's an upcoming complimentary webinar that will be addressing this subject. It's titled, "Demonstrating Value through PROs: Label Claims and Promotional Claims"
Here are the details:
Date: -----Thursday, November 5, 2009
Time: -----10:00-11:00 AM EST
Format: --Speaker presentations with Questions/Answers discussion
Since the release of the FDA’s 2006 “Guidance for Industry” on patient-reported outcomes (PROs), the field of Health Outcomes has faced increasing challenges in demonstrating evidence to support the inclusion of PROs in product labels and promotional claims. While many of our clients view this as a formidable challenge, there have been some recent success stories with products that have achieved PRO label language from FDA. Not too long ago, it was clear that providing evidence on safety and efficacy was the highest hurdle set by the FDA. Today, virtually all drug companies face additional hurdles set by Payers, who require evidence to demonstrate the value of products and key differentiators to justify access and reimbursement. In this session, we will discuss the successes and challenges associated with PRO labeling and promotional claims.
• Defining PROs according to the FDA’s Draft Guidance
• Discussion of recent products that have achieved PRO label language
• Explanation of value, as defined by the Payer audience
• Results from UBC’s Center for Health Outcomes Research’s review of PRO label language
- William R. Lenderking, PhD Senior Research Leader, United BioSource Corporation, Center for Health Outcomes Research
- Sajjad Khan, PhD, MSW, LCSW-C Senior Research Associate, United BioSource Corporation, Center for Health Outcomes Research
To Register: --Please email email@example.com to receive registration information.