All links provided below will direct you to the respective resource on the FDA website.
I am working on an imaging drug – where can I get started?
I am working on a radiation therapy – where can I get started?
I am working on an orphan drug/rare disease – where can I get started?
Webinars on topics related to development of products intended to treat rare diseases
Resources for developing products for rare diseases
Orphan Drug Designation request form and related webinar (drugs and biological products)
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 companion diagnostic device where - can I get started?
I am working on a small molecule product - where can I get started?
I am working on a biologic antibody product - where can I get started?