What is a treatment IND and how is it granted?
The treatment IND [21 CFR 312.34 and 312.35] is a mechanism for providing eligible subjects with investigational drugs for the treatment of serious …
When do you need an IND for an investigational drug?
A Treatment IND/sIND allows an experimental drug (or biologic) to be used to treat a patient while clinical testing and FDA review are still taking place. It is only approved for serious or life-threatening conditions.
Do treatment IND studies require IRB review?
Treatment IND means treatment Investigational New Drug Application authorized by competent authority (a) when used for a patient suffering from a chronic, severe or life-threatening disease for which no satisfactory authorized alternative therapy exists or (b) when otherwise approved for use by a competent regulatory authority for use for an individual under a doctor’s care but …
What should be included in an IND?
· It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist. Treatment IND is submitted for experimental drugs showing...
What are the uses of IND?
An Investigational New Drug (IND) is a drug or biological product that has not been approved for general use by the Food and Drug Administration (FDA). It is used in a clinical trial to investigate its safety and efficacy. The term also includes biological products that are used in vitro for diagnostic purposes.
What is the purpose of investigational new drug IND application?
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
What is an IND in healthcare?
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has ...
What form is used for IND?
Form FDA 1571 - IND Application Form FDA 1571 is used for two purposes: 1) to obtain agreement from the sponsor (or sponsor-investigator) to conduct research according to all appropriate FDA regulations; and 2) to serve as a cover sheet for all submissions to the FDA on behalf of a particular IND.
What is a research IND?
In comparison, a research IND (also called a non-commercial IND) is one for which the sponsor (generally an individual investigator, academic institution or non-profit entity) does not intend to later commercialize the product.
What is IND in industrial pharmacy?
An IND is a submission to the food and drug administration (FDA) requesting permission to initiate a clinical study of a new drug product. Read more. Sagar Savale. M. Pharm (Pharmaceutics)
What is the purpose of case report form?
A Case Report Form (CRF) is a printed or electronic document that is created and used in clinical trial research to capture standardised clinical data from each patient separately and to transfer it to Data Management.
What does IND stand for?
Definition of IND (Entry 4 of 5) investigational new drug.
Which is an important component of drug accountability?
The study monitor is the key to ensuring accurate drug accountability. During routine visits, monitors should assess the site's drug preparation and dispensing procedures, as well as subject compliance, and ensure proper drug storage and log maintenance.
What is IND submission?
An Investigational New Drug Application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug that is not the subject of an approved new drug application.
What are IND enabling studies?
The purpose of IND-enabling studies is to secure approval to conduct the first-in-human clinical trials with a new drug. An IND application contains information on pharmacology and toxicology, manufacturing (e.g., composition, production, stability, etc.), human clinical study protocols, and investigator information.
Do you need IND before Phase 1?
CLARIFICATIONS OF PRESENT IND REGULATIONS An IND submission for Phase 1 studies is required by regulation to contain the sections enumerated below. Clarifications are described when appropriate beneath each section heading.
What is IND/IDE support office?
Additionally, the IND/IDE Support Office is a resource for investigators who would like to consult regarding study protocol design.
How long does it take for a drug to be administered?
The investigational drug administration needs to occur within several days to weeks for a patient. A serious or immediately life-threatening disease or condition exists, and there is no comparable or satisfactory alternative therapy to treat, monitor or diagnose the disease or condition in a patient.
Is IND approved for serious conditions?
It is only approved for serious or life-threatening conditions. Examples of when a Treatment IND/sIND may be needed: A CHOP physician is caring for an individual patient who may benefit from the use of an investigational drug (or biologic).
Introduction
Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement.
Resources for IND Applications
The following resources include the legal requirements of an IND application, assistance from CDER to help you meet those requirements, and internal IND review principles, policies and procedures.
Abstract
syn. treatment use, named patient use; FDA: “A t.IND is a special case of an IND ( investigational new drug) where the only protocol under the IND is the treatment protocol.
Keywords
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
What is an IND in clinical trials?
Clinical investigators invoke a number of specific regulatory requirements if their study includes use of a pharmaceutical agent. Studies using a drug that has not been approved by the Food and Drug Administration (FDA) or for indications not in the approved labeling may require filing an Investigational New Drug (IND) application with the FDA. If a study meets specific regulatory exemption criteria, then an IND may not be needed. Individual investigators may meet the FDA definition of a sponsor-investigator, in which case the application process is generally less complicated than for commercial sponsors, and this review addresses only this circumstance. Filing an IND requires completion of 3 sets of forms: 1 detailing the study (FDA Form 1571), 1 providing information about the investigator and study site (FDA Form 1572), and 1 certifying that the study is registered in the national database of clinical trials (FDA Form 3674). If the IND is approved, the study may begin 30 days after the FDA acknowledges receipt and assigns an IND. If the FDA requires additional information or if the study is placed on a “clinical hold,” the study must not proceed. While the IND is active, the investigator must also continue to meet a set of regulations for monitoring the study and reporting to the FDA.
What is the purpose of an IND?
The stated purpose of an IND is “to ensure that subjects will not face undue risk of harm” in a clinical investigation that involves the use of a drug.8Hence, to authorize a drug study in humans, the FDA requires sufficient information to assess the safety of the intended research study. The IND is the mechanism by which by the investigator or sponsor provides the requisite information to obtain authorization to administer an investigational agent to human subjects (or an approved drug used for a new indication or a new population of patients). All studies that use a drug not approved for marketing by the FDA will always require an IND. By a rather broad set of definitions for a “new drug,”9all studies using not only new molecular entities or unapproved pharmaceuticals but also approved drugs used in unapproved indications, in new formulations, in new dosages, in a patient population that would be put at increased risk require an IND. Under specific criteria, an exemption from this IND requirement may be met.
What is the exemption for a drug study?
For sponsor-investigators initiating a study with an approved drug, the exemption that most directly relates to safety issues is CFR 312.2 (b) (iii). This criterion addresses whether the study “significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product” specifically regarding a route of administration, dosage level, dosage form, new proportions, use in a patient population, or any other relevant study aspect that affects safety of drug use. For example, this might include an exemption for studying the use of a drug in a disease entity not in the approved labeling but is reasonably supported by the underlying pharmacology and without any anticipated increase in the risk of adverse effects from the drug for the study population.
Do you need an IND for a placebo?
The use of a placebo does not require an IND if the investigation does not otherwise require submission of an IND. Clinical trials that use an FDA-approved drug within the approved labeling do not need an IND. However, clinical investigations initiated by sponsor-investigators frequently make use of FDA-approved drugs in populations or indications not addressed in the approved labeling. Clearly, such studies have a markedly different risk profile than a phase 1 or 2 study with a new molecular entity. Correspondingly, the FDA has a mechanism to bypass filing an IND if specific exemption criteria are met, which address the safety of the proposed study as well as stated limits on the noncommercial intent of the study. The exemption criteria only apply to studies using marketed pharmaceuticals commercially available in the United States. These criteria are listed in CFR 312.2 (b). Importantly, all studies must also be approved by an institutional review board (IRB), and informed consent procedures must be met as set forth in 21 CFR 50 and 56 in addition to meeting the exemption criteria. Note that studies involving an “exception from informed consent” all require an IND and cannot claim an exemption under these provisions.
What is an investigator in medical?
The FDA defines an “ investigator” to be the “individual who actually conducts a clinical investigation (ie, under whose immediate direction the drug is administered or dispensed to a subject ).”2Investigators may conduct clinical studies for a sponsor. However, individual investigators who initiate and conduct a clinical study, as well as being directly accountable for the administration or dispensing of the investigational drug, are designated as a sponsor-investigator by the FDA. Clinical investigators at academic medical centers who are initiating clinical studies with a lawfully marketed drug to be used in a patient population or indication not within the official labeling often fit within this designation. Unlike a commercial sponsor initiating studies with an unapproved drug, often at multiple sites, a sponsor-investigator conducting an investigation at a single site will have a substantially less complicated filing requirement. The sponsor-investigator obtaining the IND would then be the “holder” of the IND and thus would be responsible for the associated regulatory requirements. This “simplest case” is the subject of this review.
What is a sponsor in a drug study?
For regulatory purposes, clinical investigations involving drugs are initiated by a “sponsor” who takes responsibility for the conduct of the study. This term applies to a number of different entities. A sponsor can be an individual, a commercial entity such as a pharmaceutical company, an organization, or a governmental agency. Sponsors may conduct large multicenter trials with unapproved drugs in the anticipation of submitting the results of such investigations in support of a New Drug Application or a change in the official labeling for an approved drug. Investigational New Drug applications for studies of this nature require a comprehensive dossier of information including animal studies, pharmacokinetic analyses, toxicology studies, and manufacturing information (CFR 312.23). A description of this type of complex commercial submission is beyond the intended scope of this article.
What is the primary set of federal laws establishing FDA authority as well as codification of the regulations?
The primary set of federal laws establishing FDA authority as well as codification of the regulations is the Federal Food, Drug, and Cosmetic Act. The specific section of these laws covering an IND is in Part 312 of the Code of Federal Regulations (CFR).