Compassionate Drug Use
Expanded Access (Compassionate Use) ... (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or ...
Compassionate Drug Use | Expanded Access for Cancer Drugs
Who might benefit from compassionate drug use? Patients with serious or life-threatening conditions who can't get treatment with an unapproved ...
Compassionate use | European Medicines Agency (EMA)
Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available ...
Compassionate access and emergency use
Also known as compassionate use or a single patient IND, refers to the use of an investigational (not FDA approved) drug/device to diagnose, monitor or treat a ...
Expanded Access | Information for Physicians - FDA
Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological ...
Definition of compassionate use - NCI Dictionary of Cancer Terms
Compassionate use allows patients to receive promising but not yet fully studied or approved cancer therapies when no other treatment option exists.
Understanding the challenges and ethical aspects of compassionate ...
Compassionate drug use is an important regulatory provision that is being proposed as an amendment to the New Drugs and Clinical Trial Rules, 2019.
What is a Compassionate Use Program? - WEP Clinical
Patients who wish to be enrolled into an active compassionate use program must have a treating physician willing to prescribe the drug and complete the ...
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.
'I'm Willing To Try Anything': Compassionate Use Access To ...
The patient must have a serious or life-threatening illness or condition. · The investigational drug should be under active clinical development, ...
Compassionate Drug Use in Clinical Trials - Cancer Care
Requests for the compassionate use of an investigational drug must be made via a request from the patient's doctor to the drug company.
Unapproved drug use: compassionate or cause for concern?
Compassionate use, also known as expanded access, is a method by which patients with a life-threatening or seriously debilitating disease who have no ...
Efficacy and safety of compassionate use for rare diseases
Compassionate use of investigational drug is a significant treatment option for rare disease. In general, compassionate use appears to ...
Working Group on Compassionate Use & Preapproval Access ...
It allows patients with life-threatening diseases or conditions to request investigational drugs that have completed a phase I clinical trial if these patients ...
Compassionate drug use: Current status in India - PMC - NCBI
REGULATIONS IN INDIA FOR COMPASSIONATE USE ... CDSCO complies with the Drugs and Cosmetic Act 1940 and Rules 1945 (as amended up to December 31, 2016). Although ...
Country-Level Compassionate Use Access for Patients With Serious ...
Compassionate use (CU) programs for patients with serious medical conditions provide patient access to locally unlicensed treatments (generally ...
Before It's Too Late - ASCO Publications
Compassionate use can produce data that enhance drug development for children. Introduction. Access to investigational therapies outside of a clinical trial is ...
Expanded Access Programs, compassionate drug use, and ...
EA program candidates are often patients who have tried and failed several lines of therapies and have no other options for their life- ...
Expanded Access vs. Right to Try: What Patients Need to Know
Also known as “compassionate use,” this program allows people with immediately life-threatening conditions or serious diseases or conditions to gain access to ...
Compassionate use of unauthorized drugs: Legal regulations and ...
Compassionate use by its nature creates a conflict between the needs of some patients and those of the whole society. On the one hand, for patients with serious ...