Successful Strategies for FDA Expedited Pathways for Your Drug and Device Products

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.
 

• 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 

• ​​​​​​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

• 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.

David R. Dills, Senior Consultant, Regulatory Affairs & Compliance NOVUSLIFE currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA's, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits. He has been directly involved with constructing, reviewing, and/or remediating regulatory submissions, including 510(k), PMA, IDE applications, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent for clients, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.