Expanded Access
Expanded Access - Curium Pharma
Expanded Access Policy. Currently, Curium does not offer an expanded access program and is not accepting expanded access requests for our investigational ...
Expanded Access Policy | Aveo Oncology
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 ...
Patients Expanded Access Policy - OMEGA Therapeutics
Omega Therapeutics believes participation in our clinical trials is the most appropriate way to access our investigational therapies.
Expanded Access - UC Davis IRB
Expanded Access, occasionally referred to as “compassionate use”, is a potential pathway for a patient with an immediately life-threatening condition or ...
Expanded Access Policy - Armata Pharmaceuticals
Armata believes that participation in one of our clinical trials is the most appropriate way to access our investigational drugs.
Expanded Access for Unapproved Drugs and Biologics | Research
Single Patient Use [Emergency and Non-Emergency]: · Submit an annual report within 60 days of the anniversary date that the Expanded Access IND went into effect ...
Expanded Access & Compassionate Use Requests - SpringWorks
Making a request for expanded access/ compassionate use. Requests for access to a SpringWorks investigational or unlicensed therapy must be made voluntarily by ...
Expanded Access Policy - Zentalis Pharmaceuticals
Zentalis does not provide investigational drugs to patients until there is sufficient data on the safety and efficacy of our products.
Expanded Access - Sapience Therapeutics
Expanded access is a potential pathway for a patient with a life-threatening or serious disease to gain access to an investigational medicinal product.
Compassionate Use (Expanded Access)
Healthcare Professional requests for compassionate use. If you are a Healthcare Professional and would like to make a request for compassionate use of a GSK ...
Expanded Access | Taiho Oncology, Inc.
Taiho may be able to provide pre‑approval access to an investigational drug through our Expanded Access Program. Taiho accepts requests for pre‑approval ...
Clinical trials pre-approval access - Takeda Pharmaceuticals
The use of investigational medicines outside of a clinical trial is known under various terms such as Pre-Approval Access, Expanded Access, or Named Patient ...
Early Access Care - Connecting Patients with Investigational ...
We use the FDA or each respective country's expanded access or compassionate use regulatory pathways. ... Global expertise of local regulatory requirements for ...
Expanded access policy - Lundbeck
Lundbeck has a policy regarding access to investigational products in Phase II or Phase III of development for patient treatment purposes.
Emergency Use, Compassionate Use, Expanded Access
Emergency Use is the use of a test article (drug, biologic, or device) on a human subject in a life-threatening situation in which no standard acceptable ...
Treatment Use of Investigational Agent - Penn IRB
However, some expanded access involves treatment protocols for multiple patients. Single Patient Treatment Use. Use of an investigational drug or device in an ...
Expanded Access vs. Right to Try: What Patients Need to Know
This program allows people with immediately life-threatening conditions or serious diseases or conditions to gain access to investigational medical products.
Access to Investigational Medicines - Amgen
Patients interested in seeking expanded access to an Amgen investigational product should talk to their physician.
Is this a paid program? Currently, there is a cost associated with participating in the TB006 expanded access protocol. The manufacturing of TB006 is an ...
Expanded Access Policy :: Adaptimmune (ADAP)
Patients may be eligible for treatment with an investigational therapy through programs referred to as 'Expanded Access Programs' (EAPs) or 'compassionate use'.