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Investigational New Drugs: Types and Application Procedures
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Investigational New Drugs: Types and Application Procedures
Investigational New Drugs (INDs) are at the forefront of pharmaceutical innovation and new drug development. This article outlines the importance of INDs, types of IND applications, procedures, and their implications on the pharmaceutical landscape.
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What is an Investigational New Drug?
The Investigational New Drug (IND) program is an initiative administrated by the United States Food and Drug Administration (FDA) whereby a pharmaceutical company is granted permission to begin human clinical trials on an experimental drug. A similar procedure is followed by the European Medicines Agency (EMA) in the European Union, where the IND is referred to as an Investigational Medicinal Product (IMP).
Types of Investigational New Drugs
Types of investigational new drugs under the FDA program include:
- Commercial INDs: These are filed by pharmaceutical companies that wish to obtain marketing approval for a new drug.
Emergency Use INDs: Also known as “compassionate use” or “single-patient INDs”, this application is filed for emergency use of an unapproved drug when circumstances do not allow for sufficient time to submit an IND in accordance with current regulations. An emergency use IND is usually used for conditions deemed “life-threatening” when no standard treatments are available.
Components of an IND Application
The five components of an IND application include:
- Preclinical Testing comprised of toxicology and animal pharmacology studies assessing if the compound is safe for human testing. This component includes documentation evaluating previous experience with the drug in humans.
- Manufacturing Information that includes (1) drug composition, (2) manufacturer information, (3) drug stability, and (4) controls used to manufacture the compound. This information ensures the applicant can sufficiently manufacture and supply consistent batches of the drug.
- Investigator Information disclosing the qualifications of clinical investigators that oversee the administration of the compound to the study participants. This information is typically used to determine whether the participants are qualified to fulfill duties related to the clinical trial.
- Clinical Trial Protocols comprised of detailed clinical study information used to assess whether the initial phase of the trial exposes participants to unnecessary risks.
- Other Commitments, including (1) informed consent from study participants, (2) a review of the study by an institutional review board (IRB), and (3) compliance with investigational new drug regulations.
The IND application must also include an Investigator’s Brochure disclosing the following information:
- Dose (of the study drug)
- Methods of administration
- Frequency of dosing interval
- Safety monitoring procedures
Upon submission, the FDA has 30 days to object to the IND, otherwise it automatically takes effect and clinical trials typically commence. Information for the procedures under EMA regulations is available here.
- Research or Investigator INDs: Non-commercial INDs filed by researchers to study either (1) an approved drug for a new patient population or indication, or (2) a currently unapproved drug.
- Screening INDs: INDs submitted for multiple closely related drugs to screen for preferred formulations or compounds. Upon completion, the selected compound is typically developed under a new IND application. This type of IND application is typically filed for screening esters, salts, and other drug derivatives that are pharmacodynamically similar but chemically different.
- Treatment INDs: INDs filed prior to possible FDA approval to make a pharmaceutical available for patients facing severe or immediately life-threatening conditions. Conditions covered under this scheme include schizophrenia, rheumatoid arthritis, narcolepsy, chronic depression, stroke, osteoarthritis, seizures, Alzheimer’s, and amyotrophic lateral sclerosis (ALS).
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What happens if the FDA objects to the IND application?
Several outcomes can occur if the FDA objects to an IND application, including:
- Clinical Hold: The FDA may issue a clinical hold that stops the start or continuation of clinical trials. This action is typically taken if the agency has concerns about the drug’s data or patient safety.
- Response and Communication: Following an objection, the application’s sponsor can respond to the agency’s complaints by providing clarification, additional data, or modifications to the application that address concerns related to the objection.
- Revised IND Submission: In some cases, the sponsor may need to revise and resubmit the IND application, which can involve incorporating the requested changes or providing additional data. This process may consist of several iterations of the review and response process until the FDA is satisfied with the application.
- IND Withdrawal: The sponsor may withdraw the IND application if it cannot address the concerns related to the objection. Withdrawal of the IND typically occurs if any risks associated with the objection outweigh the benefits of drug development.
- FDA Disapproval: In some cases, the FDA rejects the application. Disapproval of the IND application usually occurs if there are significant safety risks or if there is insufficient data supporting proposed clinical trials.
- Appeals Process: The sponsor may choose to request an appeal or dispute resolution process, allowing for further modification of the application or evaluation of issues arising from the application’s rejection.
Learn More About Investigational New Drugs
Staying informed about INDs is crucial to the long-term viability of your research practice, education program, or pharmaceutical business. MedicaPharma, an EU-based pharmaceutical distribution partner, can assist you with expertise and offer access to GMP-certified APIs and pharmaceutical intermediates for research or commercial endeavours.
Contact us to learn more about investigational new drugs and their impact on your business.
Investigational New Drug FAQ
Investigational New Drugs (INDs) significantly impact the pharmaceutical industry by driving innovation, refining development strategies, and strengthening the regulatory process.
Investigational New Drugs (INDs) and New Chemical Entities (NCEs) are related pharmaceutical industry concepts, however they differ in terms of drug development. NCEs contain unapproved active pharmaceutical ingredients (APIs) while INDs are developed drugs undergoing approval before clinical trials.
Yes, investigational new drugs (INDs) can be accessed by patients through safety trials conducted by pharmaceutical companies. Following approval by the US Food and Drug Administration (FDA) or the EU European Medicines Agency (EMA), INDs are available via the clinical trial process.
The five components of an Investigational New Drug (IND) application include: (1) preclinical testing to assess the compound’s safety, (2) disclosure of manufacturing information, (3) investigator information that discloses the investigator’s qualifications, (4) clinical trial protocols, and (5) commitments that include informed consent, institutional review board (IRB) evaluation, and compliance with investigational new drug regulations.
Contact MedicaPharma to learn more about investigational new drugs, their impact on your business, and how they move through the regulatory approval process.
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