Compassionate Use

SOP IRB 1003 Compassionate Use: Investigational Drugs and ...

Expanded access pathways, also referred to as “compassionate use”, are designed to make investigational medical products available as early in the drug and ...

Efficacy and safety of compassionate use for rare diseases

Compassionate use is a system that provides patients with expedited access to drugs which has not yet been approved, but currently in ...

Compassionate Use and Expanded Access - DIPG.org

Compassionate Use of DIPG / DMG Treatments. Compassionate use of a therapy or compound is a formal channel recognized by the FDA to grant permission for a ...

Division of Medical Ethics Working Group on Compassionate Use ...

Division of Medical Ethics Working Group on Compassionate Use & Preapproval Access. The mission of the Working Group on Compassionate Use and Preapproval Access ...

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 ...

Compassionate Use - Expanded Access - LSU Health New Orleans

COMPASSIONATE USE OF A DEVICE WITH AN IDE · You wish to use the unapproved device on a single patient; · The patient has a serious disease or condition for ...

Compassionate Use Policy - Direct Biologics

The following is Direct Biologics' expanded access, also known as compassionate use, policy for drugs that are intended to treat serious diseases.

Compassionate Use Policy - Curis, Inc

Compassionate Use Policy · The patient has a serious or life-threatening illness or condition · The patient has exhausted all available treatment options ...

Compassionate Use and Expanded Access - Vivet Therapeutics

Expanded Access, sometimes called Compassionate Use, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or ...

Compassionate Use of Remdesivir for Patients with Severe Covid-19

In this report, we describe outcomes in a cohort of patients hospitalized for severe Covid-19 who were treated with remdesivir on a compassionate-use basis.

Compassionate use programme - Medicines Evaluation Board

The MEB can give permission for bringing a medicinal product on the market which has not (yet) been granted a marketing authorisation, known as a compassionate ...

Access to investigational medicines outside of a clinical trial - Roche

This could be for a group of patients through local PAA Programs such as an Expanded Access Program or for individual patients through Compassionate Use.

Compassionate Use: An Option Beyond Standard of Care

compassionate use”—treating with drugs (or medical devices) different from the standard of care—can bring hope to an otherwise dark situation.

Pre-approval access to investigational medicines

... compassionate use” (which we call “Pre-Approval Access”). This is an important topic for our company, as we know that many of the patients ...

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 ...

Patients and Caregivers - Compassionate Use Statement

This is sometimes called “expanded access,” “right to try,” “compassionate use,” “early access,” or a “named patient program.” We use the term “compassionate ...

Patients Need Not Wait: Evolving Compassionate Use and Named ...

Through compassionate use programs (otherwise known as named patient programs or special access schemes), patients suffering from critical, life-threatening ...

Compassionate, expanded access and emergency use of drugs ...

Expanded access, also known as compassionate use or a single patient IND, refers to the use of an investigational (not FDA approved) drug/device to diagnose, ...

Expanded Access to Investigational Products - Daiichi-Sankyo US

... access,” “compassionate use,” or “early access”). Granting access to an investigational medicine through a Medical Access program should not delay ...

Compassionate use - Corcept Therapeutics

If the physician determines that the patient does not qualify for an ongoing clinical trial, Corcept may provide investigational medication through ...