Understanding INDs and NDAs in Clinical Research

If you’re considering a career in clinical research or the broader pharmaceutical and biotech industry, you’ve likely come across terms like IND and NDA. But what do these acronyms really mean, and why are they so important in drug development?

IND stands for Investigational New Drug application. It’s the very first regulatory green light a sponsor must secure before beginning clinical trials in humans.

An IND is more than just a form. It includes a comprehensive package of documents and data, such as: 

• Preclinical study results (including pharmacology and toxicology data) 
• Manufacturing information about the drug compound 
• Clinical trial protocols describing how the study will be run 
• Investigator brochures that explain the investigational product to clinical researchers 
• Informed Consent Forms (ICFs) to ensure participants are aware of the risks 

The IND must demonstrate that the drug is reasonably safe for initial human testing, typically starting with a Phase I clinical trial.

Once an IND is submitted, the FDA has 30 days to review it. If the agency doesn’t raise objections, the sponsor may proceed with human testing.

The New Drug Application (NDA) is submitted to the FDA to demonstrate that a new pharmaceutical product is safe and effective for its intended use. 

The application includes: 

• Data from all phases of clinical trials 
• Information on drug formulation and manufacturing 
• Details on labeling, dosage, and instructions for healthcare providers 
• A risk-benefit analysis for regulators to assess 

In other global markets, the equivalent process may involve other authorities like the EMA (European Medicines Agency) in Europe or PMDA in Japan. While the terminology may differ (e.g. a Marketing Authorisation Application (MAA) in the EU), the fundamental concept is similar.

Aspect                      IND (Investigational New Drug)                 NDA (New Drug Application) 

Purpose                    Request to start clinical trials                    Request to market/sell the drug 

Submission              Before Phase I trials begin                        After successful completion of Phase III

Submitted To           FDA (or other national authorities)            FDA (or other national authorities)

Focus                        Safety for testing in humans                     Efficacy and safety for public use

Includes                   Preclinical data, trial protocols                  Full clinical trial data, labeling info

Both INDs and NDAs are subject to intense scrutiny, and the regulatory pathway is rarely smooth sailing. Challenges include: 

• Data quality and integrity: Any inconsistencies in clinical data can delay approvals. 
• Timelines: Preparing submission documents can take months, and reviews may involve back-and-forth with regulators. 
• Compliance: Regulatory requirements change frequently and vary by region. 
• Collaboration: Successful submissions require close coordination across clinical, regulatory, medical writing, and quality assurance teams. 

For those working in or pursuing careers in clinical research, it’s helpful to develop cross-functional awareness - understanding not just your immediate responsibilities, but how they contribute to the broader picture.

If you're searching for jobs in clinical trials, clinical operations, or regulatory affairs, knowing the difference between an IND and NDA helps you: 

• Understand where a project sits in the drug development pipeline 
• Speak confidently about the trial lifecycle in interviews 
• Identify the kind of experience you're gaining in a role 
• Determine what kind of sponsor or study phase you'd prefer to work on 

For example, if you're working on Phase I trials, you're operating under the scope of an IND. If you're supporting submission readiness, you're likely contributing to an NDA. 

This knowledge also helps when planning your career path. For example, professionals working in regulatory writing, clinical data management, or pharmacovigilance all play roles during different stages of these submissions.

If you’re entering the world of clinical research, here are a few roles where IND and NDA knowledge can be especially valuable: 

• Regulatory Affairs Associate/Manager Helps prepare submissions and interacts with regulatory agencies. 
• Medical Writer Drafts the clinical study reports and summaries included in applications. 
• Clinical Project Manager Oversees trial execution, ensuring milestones for IND or NDA readiness are met. 
• Clinical Research Associate (CRA) Monitors trial conduct and site compliance, ensuring data meets submission standards. 
• Quality Assurance Specialist Audits trial documentation and systems to ensure regulatory compliance. 

Understanding INDs and NDAs can also open doors to drug safety, compliance, or CMC (chemistry, manufacturing, and controls) roles.

INDs and NDAs are fundamental checkpoints in the journey of turning an idea in a lab into a life-saving medicine. For professionals in the clinical research and pharmaceutical industry, they’re also key touchpoints that shape roles, responsibilities, and even career paths. 

Whether you're applying for your first clinical research job or planning your next move, understanding these terms can give you a clearer picture of where your work fits into the big picture.