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**Obtain informed consent prior to VIGIL initiation**Expanded Access IND Protocol: Use of Vaccine Immune Globulin Intravenous (VIGIL, CNJ016) for Treatment of Human Orthopoxvirus Infection in Adults

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How to fill out expanded access ind protocol

01

Obtain the necessary forms from the FDA website

02

Complete the required information for the patient and the investigational drug

03

Submit the protocol to the FDA for review and approval

04

Implement the protocol once approved by the FDA

Who needs expanded access ind protocol?

01

Patients who have exhausted all other treatment options

02

Patients who are not eligible for clinical trials

03

Physicians seeking to provide investigational drugs to their patients

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What is expanded access ind protocol?

Expanded access IND protocol, also known as compassionate use, allows for the use of an investigational drug outside of a clinical trial for patients with serious or life-threatening conditions.

Who is required to file expanded access ind protocol?

The sponsor of the investigational drug is required to file the expanded access IND protocol.

How to fill out expanded access ind protocol?

The sponsor can fill out the expanded access IND protocol by submitting an application to the FDA.

What is the purpose of expanded access ind protocol?

The purpose of the expanded access IND protocol is to provide access to investigational drugs for patients who do not qualify for clinical trials.

What information must be reported on expanded access ind protocol?

The expanded access IND protocol must include information on the patient's diagnosis, the investigational drug being requested, and the rationale for seeking access to the drug.

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