The governing federal law makes it a compulsion for the pharmaceuticals to be subject to the marketing application for their distribution over states. Thus an IND is filed by the sponsor for exemption from the legal requirements, as the pharmaceutical is likely to transport for analysis and investigation purposes. The IND application serves as a strong foundation pillar for transition of IND to NDA (New Drug Application) for regulatory approval.
Below is the detailed explanation of IND definition, Types and more.
What Is IND (Investigational New Drug)?
IND in the pharmaceutical industry stands for Investigational New Drug which is an application file for a biological and pharmaceutical product which has not been approved yet by FDA and is being studied in clinical trials for testing its effectiveness and safety. Thus, we can call it an experimental drug.
IND serves as an important aspect for the researchers as it gives authorization for drugs to be used in humans. IND is submitted by researchers, investigators, physicians, etc. who are interested in development of drugs through scientific approach.
Types of IND for Pharmaceutical products:
Here are the different types of Investigational New Drug (IND) applications essential for pharmaceutical development and regulatory approval.
Research or Investigational IND
Emergency IND
Treatment IND
Screening IND
Research or Investigational IND:
This kind of IND is filed by the analyst to analyze a novel drug or an already approved drug to study for new uses or new patient population and explore various scientific aspects of the drug. It is mostly used for discovering new uses of an approved drug. It is majorly used by a sponsor to look over the trial design.
One such example of Research IND is investigation on human use for already existing drugs for development into new dosage form.
Emergency IND
This IND is filed in a critical situations to approve the experimental drug. It is used to study a drug on outbreak of life-threatening disease. It is also used for FDA submission after emergency treatment.
Example is administration of novel drug to patients suffering from cancer at the last stage where all available treatments have been done with no positive effect.
Treatment IND
This IND is filed for drugs that have potential of early testing for severe health crises for which the final analysis may take place with the FDA review process. This is a rapid process as compared to research or investigational IND which is used for drugs with promising clinical trials results. It provides access to non-participants of clinical trials for studying the clinical effects.
Example is use of a novel drug which has shown promising effects in the phase 3 trials by slowing down the disease progression.
Screening IND
This IND is filed for early phase clinical trials of drugs based on which further it is decided if the drug is suitable for targeted study or not. Instead of multiple INDs for each candidate, screening IND covers all related compounds and formulations. Early phase clinical trial evaluation of four molecules with same target receptors but different binding affinity for brain tumor is one such example of screening IND.
Investigational New Drug Categories:
There are mainly two categories they are as follows:
Commercial IND
This kind of IND is filed by the companies who wish to market the drug after its approval. It involves a large number of clinical trials and also involves comprehensive data on pre-clinical studies.
Research IND/Non-commercial IND
This kind of IND is filed by academic researchers for non-commercial studies. Here non-trial participants are allowed to have broader access to experimental medications.
How To Prepare An IND Application Submission?
To prepare an IND application submission, the researcher must fill a form on the FDA’s official website where he must mention about the study and the drug to be used, details about the sponsor, list of investigators and their qualifications attaching with the detailed IND file.
Steps in IND application submission:
Step 1: Recognize the structure and requirements of IND
Step 2: Consult the Regulatory Authority before to IND (optional, but advised)
Step 3: Compile the necessary information and documents
Step 4: Put the IND application in the format of a Common Technical Document (CTD).
Step 5: Send in the application for IND
Step 6: Keep an Eye on the IND Evaluation Procedure
Step 7: Follow the provided protocol to conduct the clinical trial
FDA IND Application Process:
The IND application must contain comprehensive information including the following:
IND Requirements And Regulations:
Pre-IND Stage:
In this stage, all the relevant data is collected regarding the drug and communication is established with FDA.
IND Submission:
A detailed IND application is submitted which constitutes the following parts:
Preclinical studies:
This section covers information about the animal model testing conducted including the pharmacology and toxicology studies. After checking required parameters, FDA decides whether the drug is applicable with respect to its safety for further human clinical trials or not.
Manufacturing materials:
This section provides information about the chemical makeover, controls and stability involved in the manufacture of the drug product. FDA examines this data to ensure if the pharmaceutical business can deliver reliable batches of these medicines.
Clinical Protocols and Investigator Information:
This section provides detailed protocols for the clinical trial such as informed consent protocols and external ethical review. It also mentioned the qualifications and experience of the study researchers to analyze if they are capable of carrying out a safe clinical trial.
FDA’s IND review and feedback:
Upon successful submission of the IND, one should wait for 30 consecutive days to begin the clinical trial. In this period, the FDA reviews all the data provided to evaluate the safety and efficacy of the drug and to confirm that the study participants will not face any unwanted danger to their health.
Approval or Rejection:
If the FDA does issue any “clinical hold” the researcher cannot begin with the trial unless and until the issue is resolved either by providing additional data or by changing the structure of the trial. Whereas in case if FDA does not issue any “clinical hold” within 30 days, the researcher can begin with the trial.
Post IND approval:
When moving forward, it is necessary for the researcher to keep the communication open throughout the clinical trial with FDA to report any adverse effect or any other issue which needs to be addressed.
IND Amendments and Maintenance:
The sponsor may be required to send in amendments for any revisions to CMC data, protocol changes, or inclusion of additional investigators throughout the clinical trial.
IND Transition to New Drug Application (NDA):
Following successful clinical trials (Phases I–III), the sponsor gathers all clinical and nonclinical data into a New Drug Application (NDA) for FDA review.
Challenges in the IND Application Process:
The following conditions may pose a challenge during the application process:
Indigent document which does not provide correct understanding of the clinical trial and their parameters to the FDA’s reviewers.
Usage of non-clinical data that does not provide support to clinical protocol.
Inclusion of too long and bulky content in the document which does not provide the exact understanding.
Improper description of adverse effects and potential risks in the clinical trials.
Sponsors not meeting the study data standards.
Making inadvertent mistakes in the submission of an IND application.
Benefits of Obtaining an IND:
There are several benefits to submitting an Investigational New Drug (IND) application, particularly for pharmaceutical corporations, university researchers, and healthcare providers. The IND benefits are as follows:
Legal Permission to Conduct Human Experiments
Encouraging the Development of Drugs
Protection of Study Participants and Ethical Oversight
Gaining Entry to More Opportunities
Credibility in Science and Regulation
Route to Market Approval
Adaptability in Repurposing Drugs
Final thoughts:
The path from bench to bedside for an experimental medicine is paved by a well-prepared IND application, which serves as the cornerstone for successful clinical trials and, eventually, the introduction of novel therapies that benefit patients. IND serves as a crucial regulatory element while simultaneously providing the evaluation in all aspects for the novel drug.
FAQs About IND Application
1. What is the purpose of filing an IND with the FDA?
The purpose of filing an IND with the FDA is to seek approval to begin human clinical trials for an investigational drug.
2. How long does the FDA take to review an IND submission?
The FDA typically has a 30-day review period for an IND submission. If there are no concerns, the trial can begin; otherwise, the FDA may request additional information or impose restrictions.
3. What happens if an IND application is not approved?
If an IND application is rejected, the FDA will provide reasons for rejection, which may include safety concerns, insufficient preclinical data, or inadequate clinical trial design. The sponsor may address the issues and reapply.
4. Are there different regulations for IND filing in different countries?
Yes, IND filing regulations vary across countries. While the FDA governs IND submissions in the U.S., other countries have their own regulatory bodies, like the EMA in Europe or the PMDA in Japan, each with different requirements.
5. Where is the IND application submitted?
The IND application is submitted to the U.S. Food and Drug Administration (FDA). The FDA is the regulatory body responsible for reviewing the application and determining whether the investigational new drug can proceed to clinical trials.
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