Speeding the availability of drugs that treat serious diseases is in everyone's interest, especially when the drugs are the first available treatment or if the drug has advantages over existing treatments. The Food and Drug Administration has developed four distinct and successful approaches to making such drugs available as rapidly as possible: Priority Review, Breakthrough Therapy, Accelerated Approval, and Fast Track, including the Regenerative Medicine Advanced Therapy (RMAT) Designation under CBER. Because each of these approaches implies speed, there can be confusion about the specific meaning of each and the distinctions among them. The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to provide patients and healthcare providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval and marketing authorization. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness to be authorized for marketing.
 

WHY SHOULD YOU ATTEND?

Serious or life-threatening diseases remain a large unmet medical need in the United States, as many do not currently have effective therapies. As innovative therapies are increasingly researched and developed, including regenerative medicine therapies, it is important to expedite such treatments to ensure patients are treated as quickly as possible. This presentation will focus on what these expedited review programs are, the incentives for obtaining such designations, and the required information/data to better position your investigational product for success.
 

AREA COVERED

• ​​​​​​Overview of the FDA expedited review programs and why they are vital for increasing the likelihood of advancing an investigational product to market
• Which expedited program do I qualify for?
• What are the costs, benefits, and risks of each program?
• How and when do I apply?
• Key strategic considerations and proven recommendations for choosing expedited pathway(s) for your investigational drug and medical device
• FDA guidance and resources
• Advantages and disadvantages when applying for a designation and effectively navigating through these programs
• Number of FDA-granted designations for the most recent fiscal year for the programs

LEARNING OBJECTIVES

• Learn key regulatory definitions related to the FDA expedited review programs, including Breakthrough Device Designation, FTD, BTD, and RMAT Designation
• Understand the requirements of a successful “Designation Application” and when to submit such documents
• Recognize the importance of expedited review programs and their impact on reducing drug development time
• Understand the criteria for each program
• Learn how to request your designation if the investigational product is eligible
• Identify and understand with more clarity the benefits of these programs
• Understand that despite the similar definitions and implications, each route has its own qualifications and necessary steps 

WHO WILL BENEFIT?

• Regulatory Affairs Managers, Directors, Vice-Presidents, Regulatory Specialists, Regulatory Consultants, Regulatory Leads, Regulatory Project Managers, Regulatory SMEs, Sr. Management, and other disciplines who would like to learn more about these FDA programs. The webinar will benefit regulatory professionals and pharmaceutical/biotech and medical device companies that are developing products intended to treat serious conditions with an unmet medical need, including Compliance Officers and Clinical Research and Development Teams.