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.
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.
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.
David R. Dills
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, …
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