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

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.
 

• 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 Dills is currently a Global Regulatory Affairs Consultant after departing his last company earlier this year in 2024 and a full-service CRO as Director of Regulatory Services. He is a seasoned Global Regulatory Affairs, Regulatory Strategist, and Compliance professional with demonstrated capabilities and a track record with more than 35 years of accrued experience in the functional areas of Regulatory Affairs, Regulatory Intelligence, Regulatory Compliance, Global Regulatory PM/PD, and QA/QAE for US and international developers/manufacturers/sponsors for early-stage, mid- and large-size enterprises for pharma, biologics, combination, and medical device products from investigational to marketing approval. He has worked for CROs, consultancies, and manufacturers in different roles and capacities. A key focus is regulatory strategy and bringing products from new product development from pre-clinical to global market transfer and commercial release and collaborating with the regulatory authorities and agencies. With his depth and breadth of regulatory and compliance experience, he examines all aspects of regulatory and compliance, to help companies uncover potential strategic regulatory risks while cultivating novel, targeted strategies to help companies achieve regulatory approval in multiple markets. This is to ensure that regulation provides consistent strategic messaging and cohesion throughout the entire regulatory and compliance lifecycle for the key stakeholders of the organization. He manages regulatory projects with multiple competing priorities having a direct impact on site operations, regulatory filings, approvals, and commercial opportunities. He enjoys developing and executing comprehensive regulatory strategies for companies, considering their specific business objectives regulatory requirements, and commercial considerations in global markets, and supporting sound regulatory submissions, interactions, and outcomes with regulatory authorities. This includes leading the interactions with Health Authorities on behalf of companies in formal meeting settings, including providing pre-meeting coaching and preparation of briefing documents, negotiations, and post-filing support. He enjoys providing regulatory leadership experience with a broad spectrum of indications, therapeutic areas, and product modalities at multiple phases. He has academic degrees in Biology and Environmental Science and is an active member in various professional industry groups and affiliations.