This session provides an overview of the U.S. Food and Drug Administration (FDA) policies and procedures critical for academic investigators and small businesses engaged in biomedical research and product development to understand. Attendees will gain insights into the regulatory framework governing clinical trials, drug and device approvals, and post-market surveillance. By the end of this session, participants will have a clearer understanding of the FDA’s expectations and requirements, enabling them to navigate the regulatory landscape more effectively and bring their innovations to market with greater confidence. Come hear speakers from industry and regulatory agencies share their perspectives and advice on incorporating regulatory requirements into product development and how to achieve successful regulatory strategies.

Host

Ramesh Raghavachari FDA (United States)

Tissue phantoms as regulatory science tools to support medical device development

William C Vogt FDA/CDRH (United States)

NIBIB opportunities toward technology development and standardization

Afrouz Anderson NIH/NIBIB(United States)

Unlocking the value of optical tissue phantoms: accelerating clinical translation for medical innovation

Ethan LaRochelle QUEL Imaging Inc. (United States)

 

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Event Details

FORMAT: Oral presentations followed by audience Q&A.
MENU: Coffee, decaf, and tea will be available nearby
SETUP: Theater style seating.