Definitions for expanded access
ex·panded ac·cess

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1. Expanded access

   Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. These programs go under various names, including early access, special access, or managed access program, compassionate use, compassionate access, named-patient access, temporary authorization for use, cohort access, and pre-approval access.In general the person and his or her doctor must apply for access to the investigational product, the company has to choose to cooperate, and the medicines regulatory agency needs to agree that the risks and possible benefits of the drug or device are understood well enough to determine if putting the person at risk has sufficient potential benefit. In some countries the government will pay for the drug or device, but in many countries the person must pay for the drug or device, as well as medical services necessary to receive it. In the US, compassionate use started with the provision of investigational medicine to certain patients in the late 1970s, and a formal program was established in 1987 in response to HIV/AIDS patients requesting access to drugs in development. An important legal case was Abigail Alliance v. von Eschenbach, in which the Abigail Alliance, a group that advocates for access to investigational drugs for people who are terminally ill, tried to establish such access as a legal right. The Supreme Court declined to hear the case, effectively upholding previous cases that have maintained that there is not a constitutional right to unapproved medical products.

How to pronounce expanded access?

1. Alex

   US English

   David

   US English

   Mark

   US English

   Daniel

   British

   Libby

   British

   Mia

   British

   Karen

   Australian

   Hayley

   Australian

   Natasha

   Australian

   Veena

   Indian

   Priya

   Indian

   Neerja

   Indian

   Zira

   US English

   Oliver

   British

   Wendy

   British

   Fred

   US English

   Tessa

   South African

How to say expanded access in sign language?

Numerology

1. Chaldean Numerology

   The numerical value of expanded access in Chaldean Numerology is: 1

2. Pythagorean Numerology

   The numerical value of expanded access in Pythagorean Numerology is: 6

Examples of expanded access in a Sentence

1. Anand Shah:

   Per policy, we are not able to comment on whether or not we will take any action regarding emergency use authorization for convalescent plasma and will render a decision at the appropriate time, of note, the safe use of convalescent plasma remains available to patients through several pathways, including clinical trials, a national expanded access protocol, or through a single patient emergency investigational new drug request.

2. Kurt Altman:

   What the 99 percent figure does not tell us is how many terminal patients did n’t know about expanded access, had a doctor with insufficient time to complete the process, etc..

3. Pierre Bourdage:

   With this agreement, we hope to build on our MS experience with small molecules and complex generics and ultimately provide patients with expanded access to a (disease-modifying treatment) that healthcare systems may otherwise not be able to provide.

4. Steven Joffe:

   About 10 % of the time, the FDA, when it gets requests for expanded access, will say,' Yes, but here's the way you can do it more safely' or' here's the side effects to look out for,'.

References

1. ^ Wikipedia
   https://en.wikipedia.org/wiki/Expanded_Access