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Expanded Access to Unapproved Drugs, Biologics, or Devices And Right to Try Laws

Announcements

Expanded Access - Single Patient
Expanded Access - Groups
Right to Try

There are two options for treating patients with an unapproved test article outside of a clinical trial. One option is Expanded Access, which is categorized into single patient, intermediate group, and large group. The other option is Right to Try which is specifically for single patient. The IRB must prospectively approve Expanded Access and Right to Try requests. The only exception is Emergency Use under Expanded Access, Single Patient.

Expanded Access to Unapproved Drugs or Biologics

Under FDA regulations (21 CFR 312.300), expanded access allows for the use of unapproved drugs and biologics outside of a clinical trial for patients with serious diseases or conditions when there is no satisfactory alternative therapy to treat the patient’s disease or condition. This is sometimes referred to as compassionate use or treatment use. While expanded access is not considered a clinical investigation, FDA submission and IRB review are required.

Key Definitions:

Immediately life-threatening disease or condition means a stage of disease in which there is reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.

Serious disease or condition means a disease or condition associated with morbidity that has substantial impact on day-to-day functioning. Short-lived and self-limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible, provided it is persistent or recurrent. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.

Criteria for all expanded access uses for drugs and biologics:

The FDA must determine that:

  1. The patient or patients to be treated 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;
  2. The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated; and
  3. Providing the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.

Types of expanded access for drugs and biologics

Under FDA’s current regulations, there are three categories of expanded access as shown in the diagram below.

expanded access

Single Patient Expanded Access, Non-Emergency Use

In addition to the criteria for all expanded access uses, the following must also be met:

  1. The physician must determine that the probable risk to the person from the investigational drug is not greater than the probable risk from the disease or condition; and
  2. FDA must determine that the patient cannot obtain the drug under another IND or protocol.

If the drug is the subject of an existing IND, the expanded access IND submission to the FDA may be made by the sponsor or by a licensed physician.

Procedures for IRB submission of single patient, non-emergency expanded access protocols

To streamline the submission process for individual patient expanded access INDs, the FDA has developed Form FDA 3926. Physicians may use this form to request expanded access to an investigational drug outside of a clinical investigation, or to an approved drug where availability is limited by a risk evaluation and mitigation strategy (REMS). FDA generally intends to accept submission of a completed Form FDA 3926 to comply with the IND submission requirements. Form FDA 3926 may also be used for certain follow-up submissions to an individual patient expanded access IND. In lieu of approval by a convened IRB, FDA guidance allows for review and approval of Form FDA 3926 by an IRB chair or by a designated IRB member, before the treatment use begins. The FDA provides guidance on How to Request Single Patient Expanded Access.

Single Patient Expanded Access, Emergency Use

In an emergency situation that requires the patient to be treated before a written submission can be made, the request to use the investigational drug for individual patient expanded access may be made by telephone (or other rapid means of communication) to the appropriate FDA review division. Authorization of the emergency use may be given by an FDA official by telephone, provided the physician explains how the expanded access use will meet the FDA requirements of 21 CFR 312.305 and 312.310 and agrees to submit an expanded access application within 15 business days of FDA’s initial authorization of the expanded access use. The physician may also choose to use Form FDA 3926 for the expanded access application. According to FDA regulations (21 CFR 56.102(d)), emergency use is the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval. Life-threatening, for the purposes of section 56.102(d), includes the scope of both life-threatening and severely debilitating, as defined below.

  • Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the patients must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.
  • Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.

The FDA emergency use provision is an exemption from prospective IRB review and approval for one emergency use of a drug or biologic. FDA regulations require that any subsequent use of the investigational product at the institution have prospective IRB review and approval. However, in guidance documents, FDA acknowledges that it would be inappropriate to deny emergency treatment to a second individual if the only obstacle is that the IRB has not had sufficient time to convene a meeting to review the protocol.

Procedures for IRB submission of single patient, emergency use protocols

The FDA provides an Emergency IND Timeline for Submission of Single Patient Application for Emergency Use. The UCI IRB requests that, when possible, the IRB be notified in advance of the proposed emergency use of an unapproved drug or biologic by completing the Notification Form: Emergency Use of an Investigational Drug or Biologic Product. There are two parts to this form. Part I must be completed prior to the emergency use of the unapproved drug or biologic. Part II is required to be completed and provided to the IRB within five business days after the emergency use. The IRB Chair or Vice Chair will review and acknowledge the emergency use. Note that acknowledgment of the emergency use by the IRB Chair or Vice Chair should not be construed as IRB approval. IRBs are informed of Emergency Use situations during convened IRB meetings.

In the event of a waiver of informed consent for an emergency use, the IRB Chair or Vice Chair will confirm that both the physician holding the emergency IND and a physician who is not otherwise participating in the emergency use have certified in writing all of the following:

  • the patient is confronted by a life-threatening situation necessitating use of the test article;
  • informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from, the patient;
  • time is not sufficient to obtain consent from the patient’s legal representative;
  • no alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the patient’s life;

If, in the physician’s opinion, there is not sufficient time to obtain an independent physician’s determination that the four criteria are met, the physician holding the emergency IND should make the determination and subsequently obtain (i.e., within five business days) a review of his/her determination by a physician not participating in the emergency treatment.

Other Treating Physician Responsibilities:

  1. Consult with Clinical Trials Team in Sponsored Projects Administration to determine whether an agreement is necessary with the sponsor/manufacturer.
  2. Consult with UCI Health Research Revenue Integrity (RRI) to determine billing implications.
  3. Consult with Investigational Drug Services pharmacy to determine drug requirements.
  4. Register the patient in OnCore, as determined by RRI.

Step by Step Instructions for Investigators: Emergency Use of a Test Article

  1. At any stage in the following process, for assistance in determining whether an emergency use of a test article in a life threatening situation meets the criteria for use, contact the UCI Human Research Protection staff at one of the following numbers (during business hours (M-F, 8-5)): IRB Administrators: 949-824-3711 or 949-824-2576.
  2. Check the List of Previous Emergency Uses of Test Articles at UCI.
  3. If the drug or biological product is not listed, contact the manufacturer to determine if the product can be made available (for one, specific patient) under the company’s IND; or if the company declines or cannot be reached, contact the FDA for an emergency IND. In either case, the appriate division at FDA must be contacted to authorize the use.
  4. Complete the entire Part I of the  Notification Form: Emergency Use of an Investigational Drug or Biologic Product.  This includes Sections I-III.
  5. Complete the Informed Consent Document for Expanded Access of an Investigational Drug or Device – this will be the consent form used to consent the patient.
  6. Submit via fax ((949) 824-1465) or e-mail the completed Part I of the Notification Form: Emergency Use of an Investigational Drug or Biologic Product and the completed Informed Consent Document for Expanded Access of an Investigational Drug or Device template to the IRB.  Part I of the Notification Form: Emergency Use of an Investigational Drug or Biologic Product must be signed by the investigator (and physician not involved in patient’s treatment – as applicable).    Provide the Sponsor Letter of Authorization for the use of the IND (if applicable) and FDA authorization.
  7. If unable to obtain prospective informed consent from the patient, the investigator should prospectively confirm with the IRB Chair that the waiver of consent is appropriate.   In addition, as part of completing Part I of the Notification Form: Emergency Use of an Investigational Drug or Biologic Product, if the investigator is unable to prospectively obtain informed consent, the investigator should proceed by following the steps outlined in Section II.  A physician not involved in the care of the patient must confirm (via signature) that the criterion for a waiver of informed consent has been met. The current biomedical IRB Chairs are Dr. Tahseen Mozaffar and Dr. Kenneth Linden.
  8. Upon receipt of the Notification Form: Emergency Use of an Investigational Drug or Biologic Product and Informed Consent Document for Expanded Access of an Investigational Drug or Device, HRP Staff will notify the IRB (i.e., the IRB Chair or a designee not involved in the patient's care). The IRB will review the documentation to determine whether the circumstances will follow regulatory or legal requirements for use of a test article.  Note: Clearance from UCIMC Health Services Administration may also be necessary.
  9. The IRB will monitor the emergency use of test articles at UCI to ensure that continued use does not occur (as this constitutes research which would require prospective IRB review and approval).
  10. Within five working days of the emergency use, the investigator must provide the IRB with follow-up information and documentation regarding the emergency use.  This is a federal requirement. To fulfill this requirement, complete and submit via fax or e-mail Part II of the Notification Form: Emergency Use of an Investigational Drug or Biologic Product.  Also, if not already done so, provide written verification of approval from the IND/IDE holder authorizing release of the test article. This may have been authorized verbally, but written confirmation should be provided.
  11. The IRB will review the completed Notification Form: Emergency Use of an Investigational Drug or Biologic Product at a convened meeting to determine whether the circumstances follow regulatory requirements for the emergency use of a test article, consent was obtained in accordance with FDA regulations, or the circumstances met the exception to the requirement for consent. The Notification Form: Emergency Use of an Investigational Drug or Biologic Product will be signed by the IRB Chair and a copy provided to the investigator.
  12. The investigator should maintain copies of all paperwork involved in the emergency use, including the Notification Form: Emergency Use of an Investigational Drug or Biologic Product signed by the IRB Chair.
  13. There will be additional paperwork and report filing as required by sponsors, drug companies, and the FDA (such as follow up/ annual reporting requirements).  This is the responsibility of the UCI investigator.  The investigator should work with their sponsor and FDA contacts to determine their reporting responsibilities.

Expanded Access for Intermediate Size Populations

FDA may permit an investigational drug to be used for treatment of a patient population smaller than that typical of a treatment IND or treatment protocol. In cases where FDA has received a significant number of requests for individual patient expanded access for the same use, a sponsor may be asked to consolidate expanded access under this category.

In addition to the criteria listed at the beginning of this section for all expanded access, the FDA must also determine that there is enough evidence that the drug is safe at the proposed dose and duration and there is at least preliminary evidence of effectiveness of the drug as a therapeutic option in the patient population. For more information about FDA requirements, please see 21 CFR 312.315.

Procedures for IRB submission of expanded access protocols for intermediate–size populations

Intermediate size expanded access protocols must be submitted through usual IRB process and requires full IRB review and approval under FDA regulations.

Expanded Access for Large Patient Populations

Expanded access protocols for large patient populations are also referred to as treatment IND or treatment protocols. This category is used for widespread treatment use of an investigational drug. In addition to the criteria listed at the beginning of this section for all expanded access, the FDA must also determine: that the drug is being investigated in a controlled trial under an IND to support a marketing application for the expanded access, or all clinical trials of the drug have been completed; the sponsor is actively pursuing marketing for approval of the expanded access; and there is sufficient data supporting safety and effectiveness of the drug for the expanded access.

Procedures for IRB submission of expanded access protocols for large patient populations

Expanded access protocols for large patient populations must be submitted per usual IRB process and require full IRB review and approval under FDA regulations.

Expanded Access to Unapproved Devices

According to FDA regulations, an unapproved medical device may normally only be used on human subjects through an approved clinical study in which the subjects meet certain criteria and the device is only used in accordance with the approved protocol by a clinical investigator participating in the clinical trial. However, FDA recognizes that there may be circumstances under which a health care provider may wish to use an unapproved device to save the life of a patient or to help a patient suffering from a serious disease or condition for which there no other alternative therapy exists. Patients/physicians faced with these circumstances may request access to investigational devices under one of the following mechanisms by which FDA may make an unapproved device available:

Key Definitions:

Unapproved medical device is a device that is utilized for a purpose, condition, or use for which the device requires, but does not have, an approved application for premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e)(the act) or an approved IDE under section 520(g) of the act (21 U.S.C. 360j(g)).

IDE - An approved investigational device exemption permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device.

Emergency Use of an Unapproved Device

As mentioned above, an unapproved device should normally only be used in human subjects if it is approved for clinical testing under an IDE and if it is used by an investigator for the sponsor in accordance with the terms and conditions of the application.

Emergency use of an unapproved device, however, may also occur when: (i) an IDE for the device does not exist, (ii) when a physician wants to use the device in a way not approved under the IDE, or (iii) when a physician is not an investigator under the IDE. The sponsor must notify the FDA within 5 days through submission of an IDE report describing the case and the patient protection measures that were followed.

Life-threatening, for the purposes of section 56.102(d), includes the scope of both life-threatening and severely debilitating, as defined below.

  • Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the patients must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.
  • Severely debilitating means diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.

Criteria: The physician who intends to use the device must determine that the following criteria are met

  • Life-threatening or serious disease or condition that needs immediate treatment
  • No generally acceptable alternative treatment for the condition exists
  • Because of the immediate need to use the device, there is no time to obtain FDA approval

FDA expects the physician to make the determination that the patient’s circumstances meet the above criteria, to assess the potential for benefit from the use of the unapproved device and to have substantial reason to believe that benefits will exist.

Under the emergency use provisions in the FDA regulations (21 CFR 56.104(c)), the emergency use of an unapproved test article is an exemption from prior review and approval by the IRB, but must be reported to the IRB within 5 working days. FDA guidance indicates that the physician should follow as many patient protection procedures as possible, including:

  • Informed consent from the patient or a legal representative
  • Clearance from the institution as specified by their policies
  • Concurrence of the IRB Chairperson
  • An independent assessment from an uninvolved physician; and
  • Authorization from the IDE sponsor, if an approved IDE exists.

Procedures for IRB submission of protocols for emergency use of unapproved devices

UCI IRB requires that, when possible, the IRB be notified in advance of the proposed emergency use of an unapproved device. The IRB notification is notified by completing the Notification Form: Emergency Use of an Investigational Drug or Biologic Product. There are two parts to this form. Part I must be completed prior to the emergency use of the unapproved device. Part II is required to be completed and provided to the IRB within five business days after the emergency use. The IRB Chair or Vice Chair will review and acknowledge the emergency use. Note that acknowledgment of the emergency use by the IRB Chair or Vice Chair should not be construed as IRB approval. IRBs are informed of Emergency Use situations during convened IRB meetings.

In the event of a waiver of informed consent for an emergency use, the IRB Chair or Vice Chair will confirm that both the investigator and a physician who is not otherwise participating in the clinical investigation have certified in writing all of the following:

  • the patient is confronted by a life-threatening situation necessitating use of the test article;
  • informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from, the patient;
  • time is not sufficient to obtain consent from the patient’s legal representative;
  • no alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the patient’s life;

If, in the investigator’s opinion, there is not sufficient time to obtain an independent physician’s determination that the four criteria are met, the investigator should make the determination and subsequently obtain (i.e., within five business days) a review of his/her determination by a physician not participating in the investigation.

NOTE: If there is an IDE for the device, the IDE sponsor must notify the FDA of the emergency use within 5 days through submission of an IDE Report (§812.35(a)(2)). This follow-up report should include a summary of the conditions constituting the emergency, the patient protection measures that were followed, and patient outcome information.

If no IDE exists, the physician should submit a follow-up report on the use of the device (description of device used, details of the case, and the patient protection measures that were followed) to:

Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Ave
Document Control Center
WO66 Rm G-609
Silver Spring, MD 20993

Other Treating Physician Responsibilities:

  1. Consult with Clinical Trials Team in Sponsored Projects Administration to determine whether an agreement is necessary with the sponsor/manufacturer.
  2. Consult with UCI Health Research Revenue Integrity (RRI) to determine billing implications.
  3. Register the patient in OnCore, as determined by RRI.

Compassionate Use (or Single Patient/Small Group Access)

FDA’s compassionate use provision is designed to provide access to an investigational device for patients who are not eligible for the clinical trial but for whom the treating physician believes the device may provide a benefit in treating and/or diagnosing their disease or condition. Compassionate use may be used only during the clinical trial for which the device is being tested. Compassionate use may be approved for a single patient or a small group of patients.

Criteria:

  • The device is intended to treat or diagnose a serious disease or condition
  • There is no comparable or satisfactory alternative device or therapy available

Prior FDA approval is required before compassionate use occurs. The sponsor of the IDE is required to submit an IDE supplement requesting approval under 812.35(a) in order to treat the patient. For further instructions about FDA requirements for the IDE supplement, please refer to the FDA website

The physician may not treat the patient identified in the IDE supplement until FDA approves the compassionate use for the intended patient. FDA will consider preliminary evidence of safety and effectiveness as well as whether the compassionate use would interview with the conduct of a clinical trial to support marketing approval. Once approved, the patient should be monitored for safety. Follow up information on the use of the device should be submitted in an IDE Report after compassionate use has ended.

Procedures for IRB submission of protocols for compassionate use of unapproved devices

Expanded access protocols for devices must be submitted per usual IRB process and require full IRB review and approval under FDA regulations.

Resources

Right to Try Unapproved Drugs or Biologics

In May 2018, the Federal Right to Try (RTT) Act was signed into law, creating a federal framework for patients to access investigational new drugs and biologics outside of clinical trials and outside of the U.S. Food and Drug Administration’s (FDA) expanded access program. The federal law enables manufacturers and physicians to provide investigational drugs to eligible patients without risk of liability. It follows California’s passage of the State’s Right to Try Act, signed into law in 2016. Similar to the federal law, the California law enables manufacturers and physicians to provide investigational products to eligible patients without risk of liability under state law. The state law also prohibits California medical boards from taking disciplinary action against physicians.

Given the stricter California law requirements for using an investigational drug without FDA approval and the additional protection the California law affords to physicians regarding licensure, UCI will comply with California’s RTT law requirements. Because the federal RTT law does not address the use of investigational devices UCI will not provide investigational devices to patients outside of the FDA’s expanded access program.

right to try

Both the federal and state RTT laws enable patients meeting certain criteria under each law to receive access to investigational test articles without FDA oversight. However, the laws differ in fundamental ways that should be considered before providing an investigational product to a patient without FDA authorization.

Federal Right to Try Act

The Federal Right to Act enables a patient with a “life-threatening” disease or condition to access investigational drugs and biologics that have completed Phase 1 testing under an FDA-approved clinical trial and which are either being actively developed or produced by the manufacturer or not placed on clinical hold. Importantly, the federal law does not address the use of investigational devices.

In order to receive an investigational drug or biologic under the federal RTT Act, the patient must:

  • Have a life-threatening disease or condition;
  • Have exhausted treatment options, as certified by the physician;
  • Be unable to participate in a clinical trial involving the investigational drug, as certified by the physician; and
  • Have given his or her written informed consent (or consent of a legally authorized representative) to the treating physician regarding use of the investigational drug.

Use of an investigational drug under the RTT is exempt from FDA requirements for review and authorization, so long as the sponsor or manufacturer of the drug is in compliance with FDA requirements applicable to investigational drugs. Note that the law does not limit compliance to the specific investigational drug that is the subject of the use.

The RTT act does require sponsors and manufacturers who have made their investigational drugs available under RTT to annually report to the FDA the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events. In turn, the FDA must make this information publicly available on its website.

Patients may be charged the direct costs of making the investigational drug available for their use. The federal RTT does incentivizes sponsors and manufacturers to make their investigational drugs available by protecting them against liability with respect to acts and omissions regarding the investigational drug. The Act also protects prescribers, dispensers, and other individuals from liability, unless the act or omission constitutes reckless or willful misconduct, gross negligence, or an international tort under state law. Finally, the Act expressly protects against liability to any person for not providing access to an investigational drug under the Act.

California Right to Try Act

The California Right to Try (RTT) Act is similar to the federal Act, though there are notable differences.

In one respect, the California law is broader than the federal right to try law as it applies to use of investigational drugs, biologics and devices that have successfully completed an FDA-regulated Phase 1 trial and remain under active investigation by the FDA. The federal law does not include devices.

In most instances, the California law imposes more requirements to obtain access to an investigational drug outside of a clinical trial.

  • The state RTT limits access to patients with an “immediately life-threatening disease or condition”, whereas the federal law only requires patients have a “life-threatening disease or condition.” Thus, under state law, the patient must be in a stage of disease in which there is a reasonable likelihood death will occur in a matter of months.
  • The treating physician and a second consulting physician must both recommend that the patient receive the investigational product, attest to this recommendation, and attest that the patient meets the criteria of the state law.
  • Specific informed consent requirements must be met. Like the federal law, a surrogate may consent on behalf of the patient consistent with California law requirements. However, the consent form must contain the information from the California Health and Safety Code - Section 111548.1(h)(1), and also must meet the requirements set forth in the California Protection of Human Subjects in Medical Experimentation Act.
  • An IRB must review and approve the protocol and consent form.

Reporting requirements between the federal and California RTT Acts also differ. While federal law requires that the sponsor or manufacturer make information available to the FDA (which the FDA must publicly post), the California law imposes an obligation upon the IRB of record to biannually report information regarding the number of requests made to the IRB for an investigational product, the status of each request, the duration of treatment, the costs of treatment paid by patients, the success or failure of the investigational product in treatment, and adverse events.

Similar to federal law, California RTT does not impose an obligation upon manufacturers to make an investigational product available to a patient. California RTT also provides that a manufacturer may recover the costs of the manufacture of the product. However, the law removes any liability upon the patient’s heirs or the patient’s health benefit plan, for any outstanding debt related to the treatment using the investigational product.

In addition, the CA RTT specifically prohibits the Medical Board of California and the Osteopathic Medical Board of California from taking any disciplinary action against a physician’s license to practice medicine based solely upon the physician’s recommendation to treat or treatment of a patient with an investigational product, so long as the protocol was approved by an IRB. The Act also provides that any actions taken pursuant to the state law by a manufacturer or any other person or entity involved in caring for the patient cannot serve as the basis for any civil, criminal or disciplinary claim or cause of action under state law.

Procedures for IRB submission of Right to Try requests for unapproved drugs or biologics

Right to Try protocols must be submitted per the usual IRB process and require IRB review and approval. Provide the following information:
• the Treatment Plan, include the cost of treatment
• Draft a Consent Form
• Signed Treating Physician Attestation

You will also need to secure a signed Consulting Physician Attestation before treatment begins. Provide a copy of the signed attestation to the IRB within 5 days from the beginning of treatment. Please see the UCI Right to Try Attestation and Consent Template.

Other Treating Physician Responsibilities:

  1. Consult with Clinical Trials Team in Sponsored Projects Administration to determine whether an agreement is necessary with the sponsor/manufacturer.
  2. Consult with UCI Health Research Revenue Integrity (RRI) to determine billing implications.
  3. Consult with Investigational Drug Services pharmacy to determine drug requirements.
  4. Ensure patient understands financial and health care considerations outlined in consent form.
  5. Register the patient in OnCore, as determined by RRI.

Resources

List of Previous Emergency Uses of Test Articles at UCI:

  • BAT AB
  • Clofazimine
  • Diethylcarbamazine
  • Epicel
  • IV Ribavirin
  • Varizig
  • Vascular Reconstruction Device and Delivery System (Codman Enterprise)
  • Yondelis
  • Gliovac
  • RO5424802 (AF-802) (Alectinib)
  • GBM6 Tumor Lysate
  • Allopregnanolone (SAGE 547)
  • Uridine Triacetate
  • Graftmaster RX Coronary Stent Graft System
  • CPI-0610
  • Indoximod
  • ONC201
  • BLU667
  • Stratagraft

Regulations:

Resources for Expanded Access:

Resources for Right to Try:

FDA

  • New!  6/3/19: FDA "Project Facilitate"
    • A new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with caner
    • "Project Facilitate" helps treating physicians submit an Expanded Access request for an individual patient

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