Compassionate use is a pathway for very sick patients to try new, promising drugs that have not yet been approved by the FDA. These medicines are called investigational or experimental drugs. The Compassionate Use Navigator provides personal assistance and provides up-to-date information and guidance on the compassionate use application process.
Understanding the process and getting access to experimental drugs can sometimes be time-consuming and confusing: for example, compassionate use is also referred to as expanded access, early access, pre-approval access, single patient IND, named patient program, or an individual patient protocol. The Compassionate Use Navigator is a one-stop resource for navigating the process of applying for investigational drugs.
We created the Compassionate Use Navigator as a service for the pediatric oncology community – physicians, families, and advocates. You can use resources on our site and request our help with a compassionate use application to drug companies, the FDA and IRBs.
The Compassionate Use Navigator provides:
- step-by-step instructions on how to apply for compassionate use;
- assistance in identifying expanded access policies and points of contact at drug companies;
- information on FDA procedures for obtaining compassionate use medications;
- information on the IRB approval process;
- forms and templates;
- an option for physicians to request help from Compassionate Use Navigator staff in completing a compassionate use application.
If you are a physician or a patient who have tried to obtain compassionate use in the past, please contribute to our database by sharing your story.
The Compassionate Use Navigator does not evaluate the merits of compassionate use requests or provide medical expertise regarding treatment options.