IND Submission: How to Prepare an Initial FDA IND Application
Preparing an Investigational New Drug (IND) submission is a critical milestone for pharmaceutical and biotechnology companies planning to begin clinical studies in the United States.
An IND application provides the FDA with the scientific, manufacturing, nonclinical, and clinical information needed to evaluate whether an investigational drug or biologic can proceed into human clinical trials.
BioBoston Consulting supports biotech and pharmaceutical companies throughout the IND submission process, from early regulatory strategy and pre-IND preparation through preparation, review, and submission of the IND application.
What Is Included in an IND Submission?
An initial IND submission generally brings together information across several major areas, including nonclinical safety, Chemistry, Manufacturing and Controls (CMC), clinical development, and regulatory documentation. FDA requirements for IND content and format are described under 21 CFR Part 312.
1. Animal Pharmacology and Toxicology Studies
Nonclinical pharmacology and toxicology information helps establish whether the investigational product is reasonably safe to begin testing in humans.
Depending on the product and development program, the IND may include:
- Pharmacology studies
- Pharmacokinetic and toxicokinetic information
- Acute and repeat-dose toxicity studies
- Safety pharmacology
- Genotoxicity or other relevant toxicology studies
- Supporting information from previous studies or scientific literature
For products already studied or marketed, existing information may sometimes support portions of the IND development program.
2. Chemistry, Manufacturing and Controls (CMC)
The CMC section describes how the investigational product is manufactured and controlled so FDA can assess its identity, quality, purity, strength, and stability.
Information may include:
- Drug substance manufacturing
- Drug product manufacturing
- Composition and formulation
- Manufacturing controls
- Specifications and analytical methods
- Stability data
- Packaging and storage conditions
- Manufacturing facilities
When relevant information is contained in an existing Drug Master File or another FDA submission, a sponsor may be able to reference that information through an appropriate Letter of Authorization or right of reference.
3. Clinical Protocols and Investigator Information
The IND includes the protocol or protocols for the proposed clinical investigation.
FDA reviews these protocols to determine whether study participants could be exposed to unreasonable or unnecessary risks.
Clinical documentation may include:
- Clinical study protocol
- Study objectives and endpoints
- Patient population
- Inclusion and exclusion criteria
- Dose and administration
- Safety monitoring
- Investigator information
- Previous human experience with the investigational product
- Investigator’s Brochure, when applicable
FDA identifies clinical protocols, investigator information, CMC information, and pharmacology and toxicology information as core elements of an IND application.
Regulatory Documents for an Initial IND Submission
An initial FDA IND submission also contains important administrative and regulatory documentation.
These commonly include:
- Cover letter
- Table of contents
- Introductory statement
- General investigational plan
- FDA Form 1571 – Investigational New Drug Application
- FDA Form 1572 – Statement of Investigator
- FDA Form 3674 – Certification of Compliance
FDA maintains the current IND forms and instructions on its official IND Forms and Instructions page.
Sponsor-investigators may also find these resources useful:
What Happens After an IND Is Submitted?
FDA generally has a 30-day review period following receipt of an initial IND application.
A clinical investigation may proceed after FDA notifies the sponsor that the study may begin, or after the 30-day period if FDA has not placed the proposed investigation on clinical hold.
Because issues involving CMC, toxicology, clinical design, or patient safety can delay a program, many sponsors address potential FDA concerns before the IND submission whenever possible.
IND Submission Consulting and Regulatory Support
A successful IND submission requires coordination across regulatory affairs, clinical development, nonclinical toxicology, CMC, quality, and medical disciplines.
BioBoston Consulting can support companies with:
- IND regulatory strategy
- Pre-IND meeting preparation
- FDA briefing packages
- IND gap assessments
- IND readiness assessments
- Nonclinical and toxicology strategy
- CMC regulatory strategy
- Clinical protocol review
- FDA Form 1571 and supporting documentation
- IND authoring and compilation
- Cross-functional IND project management
- FDA questions and information requests
- Clinical hold prevention and response
- IND amendments and annual reports
Our regulatory professionals include experienced pharmaceutical and biotechnology industry leaders who can provide both strategic guidance and hands-on execution.
Preparing for an IND Submission?
Whether you are preparing your first IND, developing a 505(b)(2) program, advancing a novel biologic, or addressing gaps identified before submission, BioBoston Consulting can help you develop a practical regulatory strategy and move your program toward the clinic.
Contact BioBoston Consulting to discuss your IND submission and FDA regulatory needs.
