CDER: My technology is...

I am working on an imaging drug – where can I get started?

Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments – June 2004

Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications – June 2004

Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies – June 2004

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

Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry – June 2018

Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations Guidance for Industry – August 2018

Guidance for Industry Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals – November 2011

I am working on an orphan drug/rare disease – where can I get started?

CDER rare diseases program

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

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Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development Draft Guidance for Industry and FDA Staff – February 2016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 companion diagnostic device where - can I get started?

FDA webpage giving companion diagnostics overview

CDRH webinar “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product” from 8/18/2016

In Vitro Companion Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff – August 2014

Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product Draft Guidance for Industry and Food and Drug Administration Staff – July 2016

I am working on a small molecule product - where can I get started?

Overview and Differences in Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development

I am working on a biologic antibody product - where can I get started?

FDA search of guidances related to biologics

FAQs on therapeutic biological products