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Hayedeh Corone

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First, what is an IND? An IND is short for “Investigational New Drug” and is an application sent to the FDA for an exemption to lawfully transport and distribute an investigational new drug (a drug that has not been approved for sale) across state lines to conduct clinical trials and to administer it to humans. In other words, an IND is required when a sponsor intends to initiate a clinical trial or clinical investigation in humans

An IND application contains information in these three areas:

1. Animal Pharmacology and Toxicological Studies

2. Manufacturing Information

3. Clinical Protocols and Investigator Information

When an IND is submitted, the sponsor must wait 30 calendar days before initiating the clinical trial, unless an early notification is sent out by the FDA permitting the investigation to start. During the 30 calendar days, the FDA may order the sponsor to delay the clinical investigation by placing it on a “Clinical Hold” if the FDA concludes that a deficiency exists in a clinical investigation.

The NDA, on the other hand, is short for “New Drug Application“. Unlike an IND that comes in during the drug development process and right before the initiation of a clinical trial, an NDA signals the end of it. An NDA acts as a basis for the FDA to control and regulate new drugs in the United States. Since 1938, every investigational new drug is required to obtain market authorization before it can be legally marketed for sale in the United States. The NDA application serves the purpose of obtaining this market authorization. If a drug developer has enough evidence from the preclinical and clinical studies that the drug is safe and effective for its intended use, the company can file an NDA application to market the drug.

The ultimate goal of an NDA is to provide enough information to permit the FDA reviewer to determine the following questions:

The documents in the NDA tell the drug’s whole story, including what happened during the development process, the ingredients of the drug are, the results of the animal studies represent, the results from clinical studies represent, how the drug behaves in the body, and how the drug is being manufactured, processed, and packaged. All of these documents are required to be organized into five modules in an eCTD (electronic Common Technical Document) format. Refer to our blog “What is a Dossier in Regulatory Affairs” to find out more about eCTD requirements.

In addition to the study and manufacturing information, the application must also contain proposed labelling, safety updates, drug abuse information, patent information, any data from studies that may have been conducted outside the United States, institutional review board compliance information, and directions for use.

Once the FDA receives the NDA application, the reviewing team first reviews it for completeness. Completed applications will be reviewed and a decision on whether to approve the drug will be made within 6 to 10 months. Uncompleted applications are subject to refusal.

Answer is posted for the following question.

What is nda in regulatory affairs?