IND and NDA are the crucial components of the navigation guide for the journey of new drug development. IND stands for “Investigational New Drug” which is an application filed by the sponsor or researcher for FDA approval whereas NDA stands for “New Drug Application” which is also an application filed for the market approval of the new drug. IND serves as the initial application in the drug approval process while NDA serves as the final application for the drug approval process.
IND Vs NDA Comparison
Below is the detailed overview of IND and NDA which gives a broad understanding of the same.
Investigational New Drug Overview:
Investigational New Drug (IND) is an application filed by the sponsor or researcher for the drug’s approval by the FDA. This is an essential clinical investigation requirement for an unapproved drug. The FDA reviews the IND in the time span of 30 days, after which the investigator can begin with the trial if the FDA does not issue any clinical hold.
New Drug Application Overview:
The next step after the IND approval and clinical trial comes the NDA filing. The moto of NDA is to give assurance to FDA about the safety and efficacy of drug, its labelling and manufacturing process. The NDA is submitted in a five-module e-CTD (Electrical Common Technical Document) format. The FDA takes a time span of 6-10 months to approve the drug or reject the application. For a more detailed understanding of IND click the given link.
Investigational New Drug Vs New Drug Application:
IND that is an investigational new drug, and NDA that is a new drug application, are great milestones in the drug development process. They both differ from each other at different stages which are explained below in the table:
| TITLE | IND | NDA |
| Submission Period | Submitted before clinical trials for approval from FDA. |
Submitted after IND approval for market access authorization by the FDA.
|
| Approval Period or Time | FDA takes 30 days to approve the IND application. | FDA takes 6-10 months to approve the IND application |
| Application Form | FDA website has form number 1571 for IND application submission. |
FDA website has form number 356h for NDA application submission
|
| Regulatory Focuses | IND focuses on safety, ethical considerations and investigator’s information. |
NDA focuses on safety, efficacy and labelling compliance of drugs product.
|
| Outcomes | IND approval leads to outcome of the initiation of clinical trials | NDA approval leads to the commercialization of drug products. |
| Regulatory Target | The regulatory bodies assure that the drug is safe for clinical trials |
The regulatory bodies assure us that the drug is effective for human use with appropriate labelling and marketing compliance.
|
| Required Data | Early clinical and Preclinical data. | Efficacy, safety and quality of drug product. |
| Post-Approval Responsibilities | Monitor clinical trials, report adverse effects, annual reports, etc. | Post-marketing surveillance, labelling changes if required. |
IND Vs NDA In Pharmacy: Key Differences
Submission Period:
The IND is submitted before the initiation of clinical trial to the FDA. The main purpose of IND is to provide all clinical trial protocols, investigator’s qualifications and drug safety information to check the safety of participants in clinical trials, whereas NDA is submitted in after the IND approval and completion of trials to get authorization for commercialization of drug product.
Review Period:
The review period for IND is usually 30 days where the FDA reviews the application and check all the mentioned aspects and decides to give approval or reject the application, on rejection the investigator needs to provide required data which is not found in the application for the approval purpose, whereas in case of NDA the FDA takes time of about 90 days to decide whether the application covers all the expected parameters, so if it should be reviewed or not. If the FDA decides to review the application, it takes a review time of about 9-12 months to grant approval or rejection to the NDA file.
Application form:
For IND filing, form number 1571 on the FDA website is required to be filed and the IND file needed to be attached, whereas in case of NDA form number 356h is required to be filled on the FDA website attaching the NDA document to the same.
Regulatory Focuses:
IND focuses on safety, ethical considerations and investigator’s information to ensure a safe initiation and continuation of clinical trial whereas NDA focuses on safety, efficacy and labelling compliance of drugs product for confirming all the parameters before market access.
Outcomes:
IND leads to the successful initiation of clinical trials upon approval by the FDA, whereas NDA results in authorization to commercialization of the drug product upon approval by the FDA.
Regulatory Target:
In IND the regulatory bodies assure us that the drug is safe for clinical trials whereas in NDA the regulatory bodies assure us that the drug is effective for human use with appropriate labelling and marketing compliance.
Required Data:
Early clinical and Preclinical data is required in IND whereas in NDA the data of efficacy, safety and quality of drug product is required.
Post-Approval Responsibilities:
To monitor clinical trials, report adverse effects, annual reports, etc. are some of the responsibilities of IND whereas post-marketing surveillance, labelling changes if required, etc. are some responsibilities of NDA.
FAQs:
What is the difference between NDA and IND application?
NDA is submitted for marketing approval of drug products whereas IND is submitted for clinical trial approval to FDA.
Can an IND lead directly to an NDA?
Yes, a successful IND application can transition to submission of an NDA application for marketing approval.
What is the role of FDA in IND and NDA?
FDA plays the role of granting approval to sponsors for IND and NDA files.
What comes first IND or NDA?
IND is filed first for clinical trial initiation approval and then on completion of trials NDA is filed for marketing authorization of drug product.
To whom should the IND and NDA be submitted?
IND and NDA should be submitted to the FDA for approval.
