115. FDA Regulations for Treatment or w88 online game Uses of Investigational Drugs

Updated June 6, 2024

The Food and Drug Administration's Expanded Access Program allows for drugs that are w88 online game (i.e., not FDA approved) to be used for treatment use outside of a clinical trial. Sometimes this is referred to as compassionate use. Treatment use is not considered a clinical investigation. However, FDA submission and IRB review are necessary. The criteria for Expanded Access are largely determined by (1) the seriousness of a patient's condition, (2) other available FDA-approved treatment options, (3) patient population size needing treatment, and (4) drug status.

FDA allows flexibility in the expanded use of investigational drugs for treatment for persons with serious or life-threatening diseases or conditions (Subpart I) and for persons with life-threatening and severely debilitating illnesses (Subpart E). See IRB policy on overview of FDA regulations, information sheets and guidance for a listing of relevant references, including the FDA Information Sheet Guidance for IRBs and Clinical Investigators: w88 online game Use of an Investigational Drug or Biologic.

IMPORTANT NOTE: Currently, neither the University nor its Affiliate sites actively conduct or manage planned w88 online game research; therefore, the University does not have policies in place for such research. Investigators interested in conducting planned w88 online game research must contact Research Integrity & Security to discuss the possibility of engaging in this type of research. As warranted, the IRB will develop and publish policy for planned w88 online game research.

Expanded Access (Treatment) Uses of w88 online game Drugs

Subpart I of FDA regulations describes the requirements for the use of w88 online game and approved drugs where availability is limited by a risk evaluation and mitigation strategy when the primary purpose of the use is to diagnose, monitor, or treat a patient's disease or condition (i.e., w88 online game uses). By authorizing such expanded access uses, w88 online game aims to facilitate the availability of such drugs to patients with serious or life-threatening diseases or conditions when there is no comparable or satisfactory alternative therapy.

General Requirements for w88 online game Uses

Step 1: Evaluate the seriousness of the patient's or patients' condition using the w88 online game's criteria

All the following criteria w88 online game be met, as described in 21 CFR 312.305(a):

  1. The w88 online game 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 w88 online game use, and those potential risks are not unreasonable in the context of the disease or condition to be treated; and
  3. Providing the w88 online game 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 Step development of the expanded access use.

Step 2: Determine the patient population size that requires w88 online game use and evaluate the drug status using the FDA's criteria

Single Patient w88 online game Use

  • Definition: 21CFR 56.102 (d); the w88 online game is in an immediately life-threatening situation
  • Criteria: 21 CFR 312.310 (a)
  • w88 online game status: The patient cannot obtain the w88 online game under another IND or protocol (21 CFR 312.310 (a)).

Single Patient Non-w88 online game Use

  • Criteria: 21 CFR 312.310 (a); the w88 online game has a serious condition and is not in an immediately life-threatening situation
  • w88 online game status: The patient cannot obtain the w88 online game under another IND or protocol (21 CFR 312.310 (a)).

Intermediate-Size w88 online game Population

  • Definition: 21 CFR 312.315; the w88 online game use of a drug for the treatment of a patient population smaller than that typical of a treatment IND or treatment protocol
  • Criteria: 21 CFR 312.315(b)
  • w88 online game status: 21 CFR 312.315(a)

Large Patient Population, i.e., w88 online game IND or w88 online game Protocol

  • Criteria and w88 online game status: 21 CFR 312.320(a)

An IND is required for all Expanded Access. An individual physician may apply to the w88 online game for an IND or may function under an existing IND held by another physician or the drug manufacturer. Some IND holders will not allow for Expanded Access to be amended to their existing IND; in this case, the physician must apply for a new IND. Consult with the IND holder to determine if an existing IND can be amended.

Step 4: Submit an Expanded Access submission to the w88 online game

Use the instructions provided in 21 CFR 312.305(b) for the w88 online game submission. These instructions must be followed for both new IND submissions and amendment submissions to existing INDs.

Step 5: Submit an application for w88 online game Review

The application w88 online game include the following:

  1. IND documentation from the w88 online game/drug manufacturer
  2. w88 online game information via an Investigator's Brochure or a package insert
  3. An informed w88 online game document

In non-w88 online game situations, treatment may not begin until the IRB has approved the Expanded Access protocol.

Step 6: After initiating the w88 online game, ensure that all case histories and adverse events are properly recorded and reported

21 CFR 312.300 describes the safeguards and records that must be in place to ensure appropriate monitoring of patient safety. The requirements are different for the type of w88 online game approved, based on patient population size. Treating physicians should ensure they are familiar with these requirements and can maintain appropriate records and oversight for w88 online game protocols.

Criteria for FDA Exceptions from General Requirements for Informed Consent for w88 online game Use

FDA regulations describe exceptions to general requirements for informed consent. The following two exceptions are relevant to w88 online game uses of test articles. The required documentation for both requirements must be submitted to the IRB within 5 working days after the use of the test article.

w88 online game Exception per §50.23, item (a): Informed consent is deemed feasible unless before use of the test article, both the investigator and a physician who is not otherwise participating in the clinical investigation certify (in writing) all the following are true:

  • The human participant is confronted by a life-threatening situation necessitating the use w88 online game test article.
  • Informed w88 online game cannot be obtained from the participant because of an inability to communicate with, or obtain legally effective w88 online game from, the subject.
  • Time is not sufficient to obtain w88 online game from the participant's legal representative.
  • No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the life w88 online game participant.

w88 online game Exception per §50.23, item (b): If it is the opinion of a clinical investigator that immediate use of the test article is required to preserve the life of the subject, and time is not sufficient to obtain the determination of an independent physician as described above prior to using the test article, the article may be used if within 5 working days after the use of the article, the clinical investigator's determinations are reviewed and evaluated in writing by a physician who is not participating in the clinical investigation.

FDA Exemption from Requirement for Prior IRB Review and Approval for w88 online game Use

The need for an investigational drug or biologic may arise in an w88 online game situation that does not allow time for submission of an IND. The FDA can authorize shipment of the test article (drug, biologic or device) in advance of the IND submission. FDA regulations describe exceptions to general requirements for informed consent. The FDA requirements and regulations for an w88 online game IND for the use of an investigational drug or biologic are slightly different than for an w88 online game use of a device. In both situations, FDA must conclude that the use is for a "serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition."

On October 3, 2017, the w88 online game issued new guidance regarding individual patient expanded access INDs. The new pathway still involves a submission to the IRB, but the IRB can now provide concurrence by the chair or another IRB member (rather than review and approval by the convened board). To use this pathway, the sponsor-investigator needs to request 'Authorization to Use Alternative IRB Review Procedures' from the w88 online game. This can be done either on form w88 online game 3926 (section 10.b.), or, if submitting using a 1571, by a separate attachment to the w88 online game. Note: This pathway is only available when a physician sponsor-investigator will hold the IND; it is not available when the pharmaceutical sponsor will hold the IND.

The required documentation must be submitted to the IRB within 5 working days after the use of the test article. FDA regulations do not provide for expedited IRB approval in w88 online game situations. There are three possible ways to proceed:

  • the IRB can provide concurrence by the chair or another IRB member for the w88 online game use (see above), provided the FDA has granted a waiver under §56.105 of the requirements in § 56.108(c), which relate to IRB review by the convened board;
  • the IRB must convene and give full board approval for the w88 online game use (e.g., if the sponsor is a pharmaceutical company and not a physician sponsor-investigator, or the FDA has concluded that a waiver of the requirement for review and approval by a convened board is not appropriate); or,
  • if the conditions of 21 CFR 56.102(d) are met (see information box to the right) and it is not possible to convene a quorum/chair concurrence within the time available, the use may proceed without any IRB approval/chair concurrence. This latter option is also known as an w88 online game Exemption from prospective IRB review.

FDA regulations at §56.104, item (c) exempt w88 online game use of an FDA-regulated test article from requirements for prior IRB review and approval if:

  • the use meets all requirements for the w88 online game use (see above); and
  • the physician using the test article reports the w88 online game use to the University IRB within 5 working days.

NOTE: Any subsequent use of the test article at the University is subject to w88 online game review.

Investigator and Sponsor Responsibilities for w88 online game Uses

Investigators’ and sponsors' responsibilities (Subpart D of w88 online game regulations) apply as follows to the extent the requirements are relevant to the expanded access use:

  • A licensed physician who administers an w88 online game drug for an expanded access use is considered an investigator (i.e., physician-investigator) and w88 online game comply with the responsibilities for investigators as itemized below.
  • An individual or entity that submits an w88 online game IND or protocol under Subpart I is considered a sponsor and w88 online game comply with the responsibilities for sponsors as itemized below.
  • A licensed physician who submits an IND for w88 online game use under is considered a sponsor-investigator and w88 online game comply with the responsibilities for sponsors and investigators.

Responsibilities of Physician-Investigators

Physician-investigators w88 online game obtain prior IRB approval for any w88 online game use unless following three conditions are true:

  1. The use of the test article is for a human subject in a life-threatening situation, no standard acceptable treatment is available, and time is insufficient to obtain prior IRB approval (see definition of "w88 online game use" at §56.102, item (d)).
  2. The w88 online game use is reported to the IRB within 5 working days (per §56.104, item (c)).
  3. Any subsequent use of the test article at the institution is subject to prior w88 online game review.

Physician-investigators must obtain legally effective informed consent as required by the IRB (unless an w88 online game exception for informed consent at CFR 50.23 (a) or (b) applies) (as described above).

Physician-investigators must report adverse w88 online game events to the sponsor.

Physician-investigators must maintain and retain accurate records that include a case history of the patient and the disposition of the w88 online game as required.

Responsibilities of Sponsors

Sponsor responsibilities are beyond the scope of this policy. Information about sponsor (and investigator) responsibilities are codified at §312 Subpart D.

Investigator-Sponsor Requirements for w88 online game Uses

Investigator-sponsors w88 online game:

  • ensure physician-investigators are qualified to administer the w88 online game drug for the expanded access use;
  • provide the physician-investigator with the information needed to minimize risk and maximize the potential benefits of the w88 online game drug (e.g., Investigator's Brochure);
  • maintain an effective IND for the w88 online game use;
  • maintain and retain adequate drug disposition records in accordance with w88 online game and institutional requirements; and
  • comply with w88 online game requirements for submission of IND safety and annual reports.
  • communicate to the IRB within 10 work days using the Unanticipated Problem form in IRBNet any problem (including any adverse) that occurred as a result of the use of the w88 online game/device.

Types of Expanded Access Uses of w88 online game Drugs

Single Patient Treatment Use of an w88 online game Drug by a Licensed Physician

FDA regulations at §312.310 specify the two criteria under which a licensed physician may administer or dispense an investigational drug for treatment use, including w88 online game use, for an individual patient.

  1. A licensed physician determined the probable risk to the person from the w88 online game drug is not greater than the probable risk from the disease or condition.
  2. w88 online game determined that the patient cannot obtain the drug under another IND or protocol.

Requires prospective IRB approval and informed consent unless the use is for w88 online game treatment and the relevant conditions have been met for expanded, w88 online game use and/or exception from general requirements for informed consent.

NOTE: The IRB may determine it would be inappropriate to deny w88 online game treatment to a second individual if the only obstacle is that the IRB has not had sufficient time to convene a meeting to review this use of the test drug.

If the w88 online game is the subject of an existing IND, the expanded access submission may be made by the sponsor, or a licensed physician as follows:

  • The sponsor amends an existing IND to include a protocol for w88 online game for an individual patient.
  • A licensed physician submitting an expanded access obtains permission from the sponsor for w88 online game to refer to any information in the IND that would be needed to support the expanded access request and provides any other required information not contained in the IND (e.g., information specific to the individual patient).

If there is an w88 online game that requires the patient to be treated before a written submission can be made, FDA may authorize the expanded access use to begin without a written submission. The FDA reviewing official may authorize the w88 online game use by telephone. The licensed physician or sponsor must provide FDA with an expanded access submission within 15 business days of FDA's authorization of the use.

w88 online game use for a single patient is generally limited to a single course of therapy for a specified duration unless FDA authorizes multiple courses or chronic therapy.

At the end of w88 online game, the licensed physician or sponsor must provide FDA with a written summary of the results of the expanded access use, including adverse effects.

w88 online game may require the sponsor to monitor expanded access uses of extended duration.

NOTE: Under DHHS regulations, w88 online game use of an investigational drug is not considered research. Patients receiving the drug are not considered research participants and the outcome of w88 online game use of an investigational drug cannot be included in any report of a research activity subject to DHHS regulations. Under FDA regulations, the w88 online game use of an investigational drug is a clinical investigation, the patient is a participant, and the FDA may require data from an w88 online game use to be reported in a marketing application.

Treatment Use of an w88 online game Drug by a Licensed Physician in an Intermediate-sized Population

Under specific conditions (see §312.315), FDA allows use of an w88 online game drug for the treatment of more than one patient when the population is smaller than that typical of a treatment IND or treatment protocol (as described below). For example, when a significant number of requests arise for individual patient expanded access to an w88 online game drug for the same use, FDA may ask a sponsor to consolidate the expanded access uses.

Requires prospective w88 online game approval and informed consent.

w88 online game uses for intermediate populations may arise when a drug:

  • is not being developed (e.g., rareness of disease/condition restricts recruitment);
  • is being studied in a clinical trial but patients requesting use of the w88 online game are unable to participate in the trial; or
  • is approved but is no longer marketed for safety reasons or is otherwise unavailable through marketing.

In addition to the criteria for all w88 online game uses (above), w88 online game uses in intermediate-sized populations require there is:

  1. enough evidence that the w88 online game is safe at the dose and duration proposed for the expanded access use to justify a clinical trial of the w88 online game in the approximate number of patients expected to receive the w88 online game under expanded access; and
  2. at least preliminary clinical evidence of effectiveness of the w88 online game, or of a plausible pharmacologic effect of the w88 online game to make expanded access use a reasonable therapeutic option in the anticipated patient population.

(See §312.315 for more information about submission requirements, and safeguards for this type of w88 online game use.)

Wide-spread Treatment Use of an w88 online game Drug by a Licensed Physician

In addition to provisions for expanded access use for treatment of an individual patient and intermediate-sized populations, FDA regulations at §312.83 and §312.320 allow for wide-spread treatment use of an w88 online game drug via a treatment protocol or w88 online game IND.

Requires prospective w88 online game approval and informed consent.

Requirements for FDA Approval of a w88 online game IND

  1. Trial status. The w88 online game must be under investigation in a controlled clinical trial under an IND designed to support a marketing application for the expanded access use or all clinical trials of the w88 online game have been completed.
  2. Marketing status. The sponsor of the IND supporting marketing must be actively pursuing marketing approval of the w88 online game for the expanded access use with due diligence.
  3. Evidence. Sufficient clinical evidence must be available to provide a reasonable basis for concluding the w88 online game drug may be effective for the expanded access use without exposing patients to an unreasonable and significant risk of illness or injury.

The sponsor is responsible for monitoring the w88 online game protocol to ensure that licensed physicians comply with the protocol and the regulations applicable to investigators.

Open Label Protocol or Open Protocol w88 online game

When a controlled trial has ended, treatment may be continued to allow participants to continue to receive the benefits of the w88 online game drug until marketing approval is obtained. These are considered uncontrolled studies that are carried out to obtain additional safety data (Phase 3 studies).

Requires prospective w88 online game approval and informed consent.

Group C w88 online game IND

FDA established the "Group C" treatment IND as an agreement between FDA and the National Cancer Institute (NCI). The Group C program allows distribution of w88 online game agents to oncologists for the treatment of cancer under protocols outside the controlled clinical trial. Group C drugs are distributed only by the National Institutes of Health under NCI protocols.

w88 online game is the primary objective. Patients treated under Group C guidelines are not part of a clinical trial. The University likely would accept the FDA waiver from the requirement for approval for Group C drugs but recognizes the University IRB may opt to review the project under its policies/procedures. Investigators wishing to provide w88 online game under a Group C IND must submit the "Guideline Protocol" for the use of the Group C drug and the FDA-approved informed consent document.

Parallel Track

Through its Parallel Track policy, w88 online game permits wider access to promising new drugs for AIDS/HIV related diseases under a separate "expanded access" protocol that "parallels" the controlled clinical trials that are essential to establish the safety and effectiveness of new drugs. It provides an administrative system that expands the availability of drugs for treating AIDS/HIV.

These studies require prospective w88 online game review and informed consent.

w88 online game Use IND

The need for an investigational drug may arise in an w88 online game situation that does not allow time for submission of an IND in the usual manner. In such cases, FDA may authorize shipment of the drug for a specified use with the requirement for the sponsor to file an appropriate application as soon as practicable.

Prospective w88 online game review is required unless:

  • all the conditions for "w88 online game use" described above and at §56.102, (d) are met; and
  • all the conditions are met for an w88 online game exemption at §56.104, (c).

FDA regulations require that any subsequent use of the w88 online game product at the institution have prospective IRB review and approval.

FDA and the University IRB acknowledges, however, that it would be inappropriate to deny w88 online game 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 issue.

Informed consent must be obtained unless the conditions for exception from general w88 online game for informed consent at §50.23 are met.

Drugs for w88 online game Uses for Persons with Life-Threatening and Severely Debilitating Illnesses

Subpart E of w88 online game regulations for w88 online game New Drug Applications (w88 online game), describes procedures to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely debilitating illnesses, especially where no satisfactory alternative therapy exists. (See life-threatening and severely debilitating in the HRPP online Policy Manual Definitions.) The decision to allow w88 online game or expanded uses of drugs for life-threatening and severely debilitating illnesses for a single participant or a group of participants is based on the following considerations:

  • When no satisfactory alternative w88 online game exists, participants are generally willing to accept greater risks from test articles that may treat life-threatening and debilitating illnesses.
  • Benefits of a w88 online game should be evaluated considering the severity of the disease being treated.

See Subpart E for the scope, and procedures and requirements (including requirement for early consultation of sponsor with FDA) for drugs intended to treat life-threatening and severely debilitating illnesses. Contact Research Integrity & Security for information about submitting a request to use an w88 online game drug for a person with life-threatening and severely debilitating illnesses.

Additional Resources

Guidance Documents