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Fast Tracking Antimicrobial Agents – FDA’s Accelerated Programs

Apr 22, 2020 | Drugs, On Demand Webinar

Fast Tracking Antimicrobial Agents – FDA’s Accelerated Programs

Presented by Sousan Sheldon, MT-ASCP, Ph.D. Independent Consultant

 

Developers of antimicrobial agents may seek an accelerated FDA review of their products under the accelerated programs such as Fast Track Designation, Breakthrough Therapy Designation, Accelerated Approval, or Priority Review and gain additional 5 years of market exclusivity by qualifying under the Limited Population Pathway for Antimicrobial and Antifungal Drugs While these submissions do not lessen the development period and regulatory requirements for approvals, these accelerated programs can help drug firms get their product to market more quickly and maintain exclusivity for additional 5 years under the GAIN Act

Learn more about these important FDA pathways that facilitate fast track product reviews from EAS Consulting Group’s independent consultant, Sousan Sheldon, MT-ASCP, Ph.D. a former Supervisory Review Officer, Senior Scientific Policy Advisor and Senior Policy Analyst at the FDA. Learn from her insights and avoid critical missteps that raise red flags and require time-consuming revisions.

 

About the Presenter

Sousan Sheldon, Ph.D.

Sousan Sheldon, Ph.D. is a former FDA International Policy Analyst for medical devices and pharmaceuticals with expertise in Asia, the Middle East and Canada. She is an expert in regulatory pathways for INDs, NDAs, ANDAs, 510(k)s, IDEs, De Novo, HDE, PMAs, and other regulatory submissions and has extensive knowledge in the development of medical devices, medical devices containing antimicrobial agents, combination products, companion diagnostic products, and applications for Clinical Laboratory Improvement Amendment waivers. She has a doctoral degree in Microbiology/Immunology from the University of North Texas.

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