Participate In Initial Industry-FDA Meetings

How to Study and Market Your Device U.S. Food and Drug Administration (FDA) (link)

The Device Development Process U.S. Food and Drug Administration (FDA) (link)

Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review U.S. Food and Drug Administration (FDA) (link)

Developing Products for Rare Diseases & Conditions U.S. Food and Drug Administration (FDA) (link)

Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting U.S. Food and Drug Administration (FDA) (link)

Working with Regulators: A Focus on the FDA Cancer Policy Institute at the Cancer Support Community (link)

FDA Patient Affairs U.S. Food and Drug Administration (FDA) (link)

Biologics License Applications (BLA) Process (CBER) U.S. Food and Drug Administration (FDA) (link)

Target Product Profile Template Health and Human Services (HHS) ASPR (link)

The Target Product Profile Webinar Center for Biologics Evaluation and Research (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) (link)

Making Data Talk: A Workbook by the National Cancer Institute National Cancer Institute (NCI) (link)

FDA Patient Affairs U.S. Food and Drug Administration (FDA) (link)

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