Frequently Asked Questions

What is C-Path? How is C-Path funded? How was it formed? You’ve got questions, we’ve got answers. View our FAQs below.

What is C-Path? FAQ Icon

Critical Path Institute, or C-Path, is a global, independent, nonprofit organization dedicated to the generation of actionable solutions to transform the medical product development process. C-Path brings together regulatory agencies, biopharmaceutical firms, universities, other non-profits, and patient groups from around the world to improve public health. Together, these stakeholders work to develop new tools and processes that can accelerate decision-making and medical product development and approval.

What is C-Path’s Mission? FAQ Icon

C-Path leads collaborations that accelerate drug development, advancing better treatments for people worldwide.

How does C-Path achieve its mission? FAQ Icon

C-Path achieves its mission by acting as an independent, neutral third party to form and lead public-private partnerships of regulatory agencies, biopharmaceutical firms, universities, and patient groups in a pre‐competitive collaboration and sharing of scientific data.

How is C-Path funded? FAQ Icon

C-Path is a public/private partnership funded by government agencies such as the *FDA, grants from foundations such as the Bill & Melinda Gates Foundation, Michael J. Fox Foundation and the Polycystic Kidney Disease Foundation, as well as fees from industry participants.

*Critical Path Institute is supported by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) and is 54% funded by the FDA/HHS, totaling $19,436,549, and 46% funded by non-government source(s), totaling $16,373,368. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.

How was C-Path formed? FAQ Icon

In 2004, in response to the FDA’s Critical Path Initiative (CPI) program — a national effort to modernize the process through which FDA‐regulated products are developed, evaluated, and manufactured–an independent 501(c)(3) was founded with the mission to “foster development of new evaluation tools to inform medical product development.” In 2005, a Memorandum of Understanding was created between FDA and Critical Path Institute.

What is the structure of C-Path? FAQ Icon

Critical Path Institute (C-Path) is an independent, nonprofit established in 2005 as a public-private partnership, in response to the FDA’s Critical Path Initiative. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. Each performs program work through consortia and separate initiatives. View all initiatives here

What therapeutic areas do C-Path’s collaborations cover? FAQ Icon

C-Path’s collaborations advance the generation of actionable solutions that help transform the drug development process for the following indications:

Alzheimer’s disease Non-Small Cell Lung Cancer
Asthma Organ Transplant
Ataxias, including Friedreich’s Ataxia Parkinson’s Disease
Depression Polycystic Kidney Disease
Duchenne Muscular Dystrophy Rare Diseases
Functional Dyspepsia Rheumatoid Arthritis
Huntington’s Disease Tuberculosis
Irritable Bowel Syndrome Type 1 Diabetes
Multiple Sclerosis

We also have expertise in the following:

Biomarker qualification Drug repurposing
Clinical outcome assessment qualification Drug safety and drug testing
Clinical trial simulation tools Evidentiary considerations for biomarker qualification
Data collaboration Patient-reported outcomes and electronic patient-reported outcomes
Data standards development Quantitative medicine – modeling and simulation
Database and data repository management Regulatory science

Please visit our Core Competencies page for more information.

What are C-Path’s Achievements? FAQ Icon

C-Path's Achievements

Can you send me your annual report or financial statements? FAQ Icon
  • Our IRS Form 990 can be found at
  • To obtain printed copies of our audited financial statements or if you have any questions, please contact us at
  • Click here to view our list of annual reports.
Is Critical Path Institute rated by any outside charity groups? FAQ Icon

Yes, we currently have the highest possible ratings on (Platinum) and (100/100).

What is your Federal Tax ID Number? FAQ Icon

Our Federal Tax ID number is 20-1991334.