Investigational New Drug Application

The Food and Drug Administration (FDA) receives roughly 1,500 investigational new drug applications (INDs) every year. An IND is the fully compiled dossier of information pertaining to the use of a drug product in a specified indication. An initial application contains full reporting on animal pharmacology and toxicology studies, manufacturing information, and clinical protocols with investigator information. Opening a new IND application is mainly used to seek approval for use of the drug product in humans in a clinical trial.

Under current federal law, in order for a sponsor of a drug product to ship their investigational drug to clinical investigators in different states, they must first seek an exemption from that legal requirement. Additionally, the FDA must approve the clinical protocol and assign a clinical investigator and provide that in the IND as safe to proceed before the drug product can be administered to human subjects. A successful IND allows sponsors and researchers to legally send their clinical drug/treatment to principal investigators and clinical study sites across the country — or produce commercial marketing campaigns.

Submitting a polished and thorough IND is critical to a study drug staying on the desired timeline. If gaps, errors, or unsubstantiated data are present in your IND, you run the risk of having your new therapy being placed on a clinical hold — possibly derailing study or use for months. This misstep can ultimately cost a business time, money, and the potential improvements in quality of life for patients.

Types of Investigational New Drug Applications


There are three types of INDs that may be submitted to the FDA: 

Investigator IND: This submission is done by a physician who both initiates and conducts the investigation, and under whose immediate direction the investigational drug is administered or dispensed.

Emergency Use IND:  This submission allows the FDA to authorize the use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21 CFR, section 312.23 or 312.20.

Treatment IND: This submission is for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place. 

Between these three types, two separate categories exist: 

Commercial – A commercial IND is sent by companies seeking the FDA approval for marketing of the treatment.

Research – A research IND is filed by clinicians looking to study an unapproved drug or to study an approved drug for a new indication or patient population.


The Investigational New Drug Application


In order for an IND to meet the grading criteria for the FDA, three areas must be sufficiently supported with full reports and/or data: 

  • Animal Pharmacology and Toxicology Studies  
  • Manufacturing Information 
  • Clinical Protocols and Investigator Information 

Within the first 30 days after the IND submission, the assigned FDA review division conducts a review of the application to determine whether the proposed investigation is safe to proceed. If the review division finds significant issues with the application, the IND may be placed on clinical hold. The IND and all following submissions to the FDA review division are now submitted via the electronic Common Technical Document (eCTD) format. This format has been established by the International Council for Harmonization (ICH), which organizes FDA submissions into 5 modules for administrative information, summaries, quality information, nonclinical information, and clinical information. Official guidance on the structure for the eCTD is provided by the ICH to assist with presenting information consistently across all regulatory agencies around the world.


How BioPharma Makes INDs More Successful


BioPharma Global’s team of industry experts is able to help both companies and individual clinicians navigate through their IND process — regardless of type or category. As IND submissions carry a high risk of delay and cost when they are put on hold, these pitfalls are best avoided with guidance from professionals who have helped consult on countless successful INDs. 

As a leader within the clinical research regulatory space, we work with a variety of industry players to ensure their work meets regulatory requirements and specifications in an effort to streamline their goals, meet deadlines, and ensure the safest outcomes. 

While we tailor every experience to each client, a brief overview of our IND process includes: 

  • Identify authors, reviewers, and subject matter experts for each IND module 
  • Provide a list of IND resource documents required/recommended for submission 
  • Provide fully formatted templates per section of the eCTD with guidance and training for use
  • Build teams with critical members to ensure open communication and accuracy of the information in IND 
  • Actively manage the project including meetings, critical action items, and decisions 
  • Provide authoring and reviewing of timelines 
  • Provide high-level review (i.e. content, quality control), publishing, and submission of IND 

We also offer full support for publishing and electronic submission to the FDA, helping aid sponsors and other organizations through every step of the IND process. If you would like a more in depth breakdown of the IND process we encourage you to check out our comprehensive whitepaper.

Biopharma Global - FDA & EMA Regulatory Affairs Consulting Services