IND and NDA Applications in the US

UpdatedSeptember 13, 2026

IND and NDA Applications in the US are important components of the regulatory pathway for new drug development. Before investigational drugs can be studied in humans and new drugs can be marketed, sponsors must comply with applicable requirements of the U.S. Food and Drug Administration (FDA).

Investigational New Drug (IND) Application

An IND enables a sponsor to conduct clinical investigations of an investigational drug in the United States under the applicable FDA regulatory framework.

The IND provides FDA with information needed to assess whether participants in proposed clinical investigations would be exposed to unreasonable risks.

Major Components of an IND

FDA describes three broad areas of information in an IND:

Animal Pharmacology and Toxicology: Nonclinical information supporting an assessment of whether the investigational drug is reasonably safe for initial testing in humans.

Manufacturing Information: Information concerning the composition, manufacture, stability and controls of the drug substance and drug product.

Clinical Protocols and Investigator Information: Proposed clinical study protocols, investigator qualifications and information supporting appropriate protection of research participants.

Sponsors must also comply with applicable requirements concerning Institutional Review Board (IRB) review, informed consent and clinical investigation conduct.

IND Review and Clinical Trial Initiation

After an IND is submitted, the sponsor generally waits 30 calendar days before initiating the proposed clinical investigation.

Additional requirements and guidance are available from the FDA Investigational New Drug (IND) Application resources.

During this period, FDA reviews the submission with particular attention to participant safety. A clinical investigation may proceed after the 30-day period unless FDA notifies the sponsor that the study is subject to a clinical hold or the sponsor is otherwise informed that it may begin earlier.

NDA Applications in the US

An NDA is the marketing application through which a sponsor seeks FDA approval to market a new drug in the United States.

The application brings together the evidence generated during drug development so FDA can determine whether the drug is safe and effective for its proposed use and whether its benefits outweigh its risks under the proposed conditions of use.

Information Supporting an NDA

An NDA generally contains extensive information concerning:

Quality and manufacturing
Nonclinical studies
Clinical safety and efficacy
Proposed prescribing information and labelling
Statistical analyses
Pharmacology and pharmacokinetics
Other information necessary to support regulatory review

FDA also evaluates whether the manufacturing methods and controls are adequate to preserve the drug’s identity, strength, quality and purity.

FDA Review of an NDA

Following submission, FDA determines whether the application is sufficiently complete to permit substantive review.

During regulatory review, FDA evaluates the submitted quality, nonclinical and clinical evidence, proposed labelling and other relevant information. Regulatory review may also involve inspections and requests for additional information.

If the application meets the applicable requirements, FDA may approve the drug for marketing under the conditions described in the approved labelling.

Electronic Submission of INDs and NDAs

The electronic Common Technical Document (eCTD) is FDA’s standard format for electronic regulatory submissions to CDER and CBER.

Commercial INDs and NDAs are subject to applicable electronic submission requirements and are submitted in eCTD format. Electronic submission requirements differ for certain noncommercial INDs, such as investigator-sponsored and expanded-access INDs, for which eCTD may be optional.

Applicants must follow the current FDA technical specifications, data standards and submission procedures when preparing electronic regulatory submissions.

For more information about the electronic submission framework and lifecycle management, see eCTD.