CDC holds an intermediate-size patient population EA-IND (IND 116,039/Protocol 6402) to allow access to and use of TPOXX for treatment of orthopoxvirus infections, including monkeypox. The EA-IND provides an umbrella regulatory coverage so that clinicians and facilities do not need to request and obtain their own INDs.
Full Answer
What is patient access and how does it work?
"Patient Access connects you to healthcare services when you need them most. Book GP appointments, order repeat prescriptions and explore your local pharmacy services.".
What is in partnership with patient access?
In partnership with Patient Access connects you to local health services when you need them most. Book GP appointments, order repeat prescriptions and discover local health services for you or your family via your mobile or home computer.
Who is the sponsor of an expanded access IND application?
The party who (1) submits a request to open an expanded access IND application and (2) receives FDA’s authorization to use the investigational product is considered the sponsor of the IND application. In the absence of any other sponsor (e.g. pharmaceutical company), the treating physician is the sponsor of the expanded access IND application.
What is the difference between compassionate use and expanded access?
Expanded access, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside ...
What is an EAP in clinical trials?
Expanded access is a regulatory mechanism by which an investigational drug can be made available outside of a clinical trial to treat patients with serious or life-threatening conditions for which there are no satisfactory treatment options.
What is the difference between expanded and Right to access?
The criteria for a patient to be eligible to request a drug under Right-to-Try are similar to Expanded Access. But with Expanded Access, the FDA determines whether the drug has the potential for a beneficial effect in a patient and an IRB must review and approve the treatment protocol.
What is the difference between compassionate use and emergency use?
Compassionate use means that the use does not meet the criteria for emergency use, and therefore prior FDA approval (IDE) is required before the device can be used. Standard IRB review and approval (like a research study) is required for neither emergency nor compassionate use.
What is an FDA EAP?
Sometimes called “compassionate use”, 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 investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable ...
Can a patient get access to a drug before FDA approval?
In general, to obtain access to a drug that is in testing but has not yet been approved, a patient must meet the entrance criteria and volunteer to participate in a clinical study of the drug. More information about ongoing clinical trials is available at ClinicalTrials.gov.
Who qualifies for right to try?
Patients who are eligible under the Right to Try Act2 meet the following criteria: • You have a life-threatening disease or condition. You have exhausted approved treatment options and are unable to participate in a clinical trial involving the drug or biologic, as certified by your doctor.
Is compassionate use same as right to try?
I've also learned a frustrating fact that no medical school teaches its students: While the FDA has a compassionate use program to allow people access to experimental drugs, it can't compel a company to provide those drugs. The newly signed “right-to-try” law doesn't either.
What is a compassionate use drug?
Compassionate drug use means making a new, unapproved drug available to treat a seriously ill patient when no other treatments are available. Drugs that are being tested but have not yet been approved by the US Food and Drug Administration (FDA) are called investigational drugs.
How long does emergency use authorization take?
For comparison, the COVID-19 vaccine from Pfizer-BioNTech, which was the first to receive an EUA, was under clinical development for six months before it submitted its EUA. An EUA was granted in less than a month; full approval was issued eight months later.
Can a physician use an unapproved device in an emergency?
Can a physician use an unapproved device in an emergency? Because of the immediate need to use the device, there is no time to use existing procedures to get FDA approval for the use. limb-threatening conditions as well as other situations involving risk of irreversible morbidity.
What are early access programs?
Early access programs are a means by which investigational therapies are made available, in certain circumstances, to treat patients with serious diseases who are unable to participate in an ongoing clinical trial or whose treatment options are otherwise limited.
What does EAP stand for in pharma?
Abbreviation for employee assistance program.
What are early access programs?
Early access programs are a means by which investigational therapies are made available, in certain circumstances, to treat patients with serious diseases who are unable to participate in an ongoing clinical trial or whose treatment options are otherwise limited.
What is named patient use?
“Named-patient basis” is another way of obtaining medicine before authorization where a doctor requests supply of an unauthorized medicine directly from the manufacturer to treat an individual patient under the doctor's direct responsibility.
What is compassionate use of a drug?
Compassionate drug use means making a new, unapproved drug available to treat a seriously ill patient when no other treatments are available. Drugs that are being tested but have not yet been approved by the US Food and Drug Administration (FDA) are called investigational drugs.
What is a LOA in medical?
If the pharmaceutical company decides to grant the request to use the investigational drug, the company’s representative will provide required documentation such as a Letter of Authorization (LOA). The physician will submit a copy of the required documentation to the FDA and Institutional Review Board ...
What documentation is needed for an investigational drug?
If the pharmaceutical company decides to grant the request to use the investigational drug, the company’s representative will provide required documentation such as a Letter of Authorization (LOA). The physician will submit a copy of the required documentation to the FDA and Institutional Review Board (IRB) later in the application process in order to verify the company has approved the physician’s use of the investigational treatment for single-patient EA. If a LOA is unavailable, the FDA still needs sufficient information to assure the product’s quality.
Who must report the treatment protocol agreed upon with the IRB and the pharmaceutical company?
As the patient undergoes treatment with the investigational treatment, the physician must follow the treatment protocol agreed upon with the IRB and the pharmaceutical company. The physician must report the following to the FDA and IRB:
What is EA in medical?
If single-patient expanded access (EA) is permitted for a patient, the sponsoring physician is required to comply with FDA reporting requirements during and after the treatment. Clinical trial outcomes are primary criteria on which FDA bases its review of a new drug. While the primary intent of expanded access is to treat a patient ...
How to contact FDA for drug information?
If you have questions, you may contact FDA’s Division of Drug Information at 855-543-3784 or [email protected] or the FDA Office of Health and Constituent Affairs at 301-796-8460, or [email protected].
What is expanded access?
Expanded access, sometimes called "compassionate use," is the use of investigational new drug products outside of clinical trials to treat patients with serious or immediately life-threatening diseases or conditions when there are no comparable or satisfactory alternative treatment options. The rules and regulations related to expanded access are ...
What is a patient benefit?
Patient (s) have a serious or immediately life-threatening disease or condition , and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; The potential patient benefit justifies the potential risks of the treatment and the potential risks are not unreasonable in the context ...
How long does it take for an expanded access IND to go into effect?
An expanded access IND application intended for IND use in non-emergency setting will go into effect 30 days after FDA receives the application or on earlier notification by FDA that the expanded access use may begin. Expanded access IND applications submitted for the purpose of clinical treatment in Emergency Setting may begin as soon as the use of investigational drug is authorized by an FDA reviewing official.
Who is the sponsor of an expanded access IND?
In the absence of any other sponsor (e.g. pharmaceutical company), the treating physician is the sponsor of the expanded access IND application.
Can expanded use of investigational drugs interfere with clinical investigations?
The expanded use of the investigational drug for the requested treatment will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the product.
