CBER: My technology is...

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

List of guidances related to combination products

Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff – February 2019

Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development Draft Guidance for Industry and FDA Staff – February 2016

I am working on a regenerative medicine therapy – where can I get started?

Expedited Programs for Regenerative Medicine Therapies for Serious Conditions Guidance for Industry – February 2019

Evaluation of Devices Used with Regenerative Medicine Advanced Therapies Guidance for Industry – February 2019

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

FAQs on therapeutic biological products