Why the IND Process Matters
Drug sponsors face a long and winding road from discovery to market. A critical step on this journey is the investigational new drug application (IND). This is the official process where a sponsor must get approval from the Food and Drug Administration (FDA) to begin clinical research on human subjects.
The IND approval process is rigorous, and for good reason, because human lives are at stake. Successfully navigating it requires early preparation and securing the right specialized knowledge. We’ll guide you through the Ind application process in detail.
Understanding the IND vs. NDA
It’s important to understand the two main stages of FDA drug approval. The investigational new drug application is the first step, allowing you to begin clinical research on a new drug. The IND doesn’t grant permission to market the drug.
The New Drug Application (NDA) is the final, comprehensive submission to the FDA. It contains all the data gathered during the entire clinical trial process. The NDA is what the FDA reviews to determine if a drug is safe and effective for widespread patient use.
Types of INDs
The FDA recognizes different types of INDs based on the purpose of the clinical research. The most common is the Commercial IND, which is submitted with the intent of obtaining market approval.
- Research IND: Filed by a licensed physician to conduct a study of an experimental drug. The physician becomes both the investigator and the sponsor.
- Treatment IND: Allows the use of an investigational drug for patients with serious or immediately life-threatening diseases. This is used when there are no satisfactory alternative therapies available.
- Emergency Use IND: Also known as Compassionate Use. This allows for the immediate use of a drug in a life-threatening situation when no other options exist and there is not enough time to submit a standard IND.
Submitting an IND Application
The review and approval process is managed by the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The same strict requirements apply to both commercial and research-focused applicants. The IND application process requires sponsors to provide detailed information across three broad areas.
- Animal Toxicology and Pharmacology Studies: Preclinical data from animal studies proving the drug is reasonably safe and effective for human testing.
- Manufacturing Information: Details on how you can consistently produce and supply the drug.
- Proposed Clinical Study Protocols: Detailed plans for the clinical trial, along with investigator qualifications and assurances of informed consent.
Once submitted, the FDA has 30 days to either approve the product for clinical trials or place the IND on a “clinical hold.” A clinical hold means the proposed study is suspended until the sponsor addresses the FDA’s concerns.
The Clinical Hold Process Explained
A clinical hold is a formal order from the FDA to delay or suspend a proposed or ongoing clinical investigation. It is a serious action that can result from a number of issues. The FDA may issue a hold if there is a concern that the drug poses an unreasonable risk to participants. It can also be due to inadequate manufacturing information or if the study design is fundamentally flawed.
When a hold is issued, the sponsor must suspend the study immediately. The sponsor then needs to work with the FDA to address the concerns and submit the necessary additional information. The FDA is required to provide a written explanation for the hold, which the sponsor must respond to. Resolving a clinical hold is often one of the most challenging parts of the entire clinical trial process.
The Clinical Trial Process
Once you get approval, you can begin testing with human participants. Clinical testing happens in three distinct phases:
- Phase 1: Conducted on a small number (20-80) of healthy volunteers to determine the drug’s basic pharmacological and toxicological effects.
- Phase 2: Administered to a larger group of patient populations (100-300) with the targeted disease. This phase focuses on determining the drug’s effectiveness, side effects, and optimal dosage.
- Phase 3: Tests the drug against a placebo with a much larger group (up to 3,000) of patients from the targeted patient populations. This phase builds a larger body of evidence and informs the FDA’s final risk-benefit analysis in the New Drug Application (NDA) approval process.
A well-designed clinical trial process is crucial for NDA success. The FDA can issue a clinical hold at any stage if safety or efficacy concerns arise.
The FDA Review Team
When you submit an investigational new drug application, it’s assigned to a team of FDA professionals. This team includes physicians, pharmacologists, chemists, and statisticians. Each member of the team focuses on a specific part of your submission. This thorough review process ensures that all aspects of your application are evaluated for scientific merit and safety.
Common Reasons for IND Delays
Setbacks in the ind application process are costly and can significantly delay getting a product to market. Many problems can be avoided with thoughtful evaluation and planning. Here are the most common reasons for delays:
- Poorly Written & Organized Materials: FDA reviewers have limited time. Your investigational new drug application must be clear, well-organized, and to the point. Include all relevant and adequate data, but avoid overwhelming them with extraneous information.
- Technical & Grammar Mistakes: Since May 2018, all commercial INDs must be submitted through the FDA’s Electronic Common Technical Document (eCTD) portal. Unfamiliarity with this process can lead to rejection due to formatting errors or missing documents.
- Not Seeking FDA Guidance: The FDA offers a pre-IND consultation program for a reason. It’s a valuable resource. The program allows new drug sponsors to have an early dialogue with the FDA and request additional information and guidance documents.
The Pre-IND Meeting & Request Process
The pre-IND meeting request is a formal submission to the FDA to schedule an initial consultation. The request should outline the meeting objectives and include a proposed agenda. The meeting process is critical for establishing a dialogue with the FDA and getting early feedback on your plans.
- Meeting Request Submission: The formal meeting request is usually filed at least 60 days before the desired meeting date.
- Background Packet: A detailed informational packet must be sent to the FDA at least four weeks before the meeting.
- Meeting Preparation: Your team should strive for total transparency. Present your scientific data neutrally and ask focused questions.
This is a prime opportunity to clarify scientific questions and demonstrate the integrity of your clinical research.
The Regulatory Attorney’s Role
Navigating the IND approval process for new therapies is a tremendous investment of time and resources. This is where a skilled regulatory attorney provides immense value. They can assist with the initial preparation of your investigational new drug application, ensuring it is complete and compliant.
An attorney can also help prepare your formal pre-IND meeting request, making sure your proposed agenda and questions are strategically aligned with the FDA’s expectations.
During the meeting process, legal counsel can help you interpret FDA feedback and structure your responses. If your IND is placed on clinical hold, a regulatory attorney can help you formulate an effective plan to address the FDA’s concerns by providing the necessary additional information and compelling scientific arguments.
The IND application process for new drug therapies is difficult and time-consuming. A skilled and experienced attorney who understands the FDA and its processes can help you streamline your application and ensure you have the greatest legal advantage.
How Crowley Law Can Support Your FDA Strategy
At Crowley Law, our focus is on guiding biotech, life sciences, and technology companies through the complex legal challenges of growth and commercialization. While our core services span entity formation, licensing, financing, and strategic collaborations, we also understand the unique hurdles that arise when bringing innovative therapies to market.
We work with founders and executives to align legal strategy with regulatory goals, and when needed, collaborate with trusted regulatory specialists who handle the technical details of FDA submissions such as INDs. This way, you get both the business and legal foundation needed to move forward, while ensuring that your FDA strategy is supported by the right expertise.
If your company is preparing for the IND process or navigating early FDA interactions, Crowley Law can provide the legal structure, strategic guidance, and connections you need to move confidently toward approval and commercialization.