All links provided below will direct you to the respective resource on the FDA website.
I am working on an orphan drug/rare disease – where can I get started?
Resources for developing products for rare diseases
Orphan Drug Designation request form and related webinar (drugs and biological products)
List of FDA webinars on topics related to development of products intended to treat rare diseases
I am working on a drug/device combination or drug delivery product – where can I get started?
FDA contacts for combination products
Request for Designation (RFD) process to assign jurisdiction to for combination products
I am working on a regenerative medicine therapy – where can I get started?
I am working on a cell-based therapy – where can I get started?
FDA webpage giving cellular and gene therapy products overview
FDA webpage with list of guidances related to cellular and gene therapies