Expanded access

Expanded access

Refers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials.

This is auto-generated content. You can help to improve it.

0 0

Improve it

Add an image

Part of Speech: noun
Synonym(s):
Blossary:
Industry/Domain: Pharmaceutical
Category: Clinical trials
Company:
Product:
Acronym-Abbreviation:

Collect to Blossary

Other Languages:

Related terms

expanded access

Health care; AIDS prevention & treatment

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 approved treatment ...

expanded access

Pharmaceutical; Clinical trials

Refers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are failing on currently ...

expanded access

Medical devices; Pharmaceutical; Clinical trials

A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who ...

expanded access trial

Health care; Cancer treatment

A way to provide an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for ...

expanded access trial

Medical; Health care; Medicine

Providing an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which ...

access

Internet; Internet communication

To obtain an open channel of communication with a software application or computer component so the user can work with it. For instance, a computer must access an attached modem ...

benzyl alcohol

Pharmaceutical; Clinical trials

(Ph.Eur. Monograph 01/2005:0256) DEFINITION Phenylmethanol. Content : 98.0 per cent to 100.5 per cent. CHARACTERS Appearance: clear, colourless, oily liquid. Solubility : soluble ...

diagnosis

Medical devices; Clinical trials

The identifying of a disease or injury by a doctor. To make a diagnosis, doctors examine a person.

combination therapy

Pharmaceutical; Clinical trials

The use of more than one medication or other therapies for the treatment of a disease.

angiotensin II receptor antagonists

Pharmaceutical; Clinical trials

Also known as angiotensin receptor blockers (ARBs), AT1-receptor antagonists or sartans, are a group of pharmaceuticals which modulate the renin-angiotensin-aldosterone system. ...

instructions for use

Biotechnology; Health care; Life Sciences; Medical; Biochemistry; Biofuel; Biomedical; Behavioral science

"a manual usually accompanying a technical device and explaining how to install or operate it" Essential Requirements - Medical Device Directive 93/42/EEC - Annex I, 13.1: Each ...