Expanded Access
Expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational ...
Expanded Access | Information for Physicians - FDA
Expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational ...
Expanded access ... These programs go under various names, including early access, special access, or managed access program, compassionate use, compassionate ...
FDA Expanded Access Program | OSF HealthCare
Expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an ...
Expanded Access | NIH - Clinical Info HIV.gov
Legal use of an investigational drug outside of a clinical trial to treat a person who has a serious or immediately life-threatening disease and who has no ...
Compassionate access and emergency use
There are three sizes of compassionate use trials: single patient, intermediate-size and expanded access (treatment IND/ widespread use). This ...
Expanded Access & Compassionate Use - Clinical Trials - Pfizer
Such individual use of an investigational drug pre-approval is often called "expanded access" or “compassionate use” but may go by other names. Pfizer refers to ...
Expanded access, also known as "compassionate use", is the use of an investigational new drug (IND) or biologic to treat a patient with a serious or ...
Expanded Access to Unapproved Drugs or Biologics
Expanded access allows for the use of unapproved drugs and biologics outside of a clinical trial for patients with serious diseases or conditions.
Overview of FDA's Expanded Access Program for Investigational ...
Expanded access is the use of an investigational new drug outside of a clinical trial in patients for the diagnosis, monitoring, or treatment of a serious ...
Expanded Access Navigator - Reagan-Udall Foundation
The Reagan-Udall Foundation for the FDA is an independent 501(c)(3) not-for-profit organization created by Congress for the purpose of advancing regulatory ...
Expanded Access Data Element Definitions - ClinicalTrials.gov
Expanded Access includes all expanded access types under section 561 of the Federal Food, Drug, and Cosmetic Act: (1) for individual patients, including ...
Expanded Access Guidance - UW Research
This webpage describes the IRB-related requirements and procedures for the mechanisms that allow expanded access to investigational drugs, devices, and ...
Expanded Access and Right to Try: Access to Investigational Drugs
In certain circumstances, FDA may allow an individual to obtain an investigational drug outside of a clinical trial through its expanded access ...
Early Access Programs - Biogen
Clinical trials are the main way for patients to access investigational drugs. Biogen's clinical trials are conducted to test the safety and effectiveness of ...
Expanded Access Program (EAP) - WEP Clinical
Expanded Access Programs. An Expanded Access Program (EAP) allows physicians and patients access to pre-approval, investigational drugs outside ...
Expanded Access Program Solutions - Early Access Care
Expanded Access Program Solutions ... Expanded Access (EA) is for unapproved drugs in advanced stages of clinical development where dosing and safety are more ...
Expanded Access Policy - Ionis Pharmaceuticals
IONIS EXPANDED ACCESS POLICY · The individual has a serious or immediately life-threatening disease or condition. · There is no comparable or satisfactory ...
Working Group on Compassionate Use & Preapproval Access ...
Expanded access requires two additional steps. If the company agrees to provide its product for that single patient, the physician must send the request to the ...
Common Questions about Expanded Access Programs
EAP stands for Expanded Access Program (EAP) and is sometimes referred to as Compassionate Use Program or Expanded Access Protocol Program.