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Investigational New Drug (IND) Application

The first step of any drug’s review process starts with filing an Investigational New Drug (IND) application. The application is submitted to the United States Food and Drug Administration (US FDA) for obtaining exemption to ship the product to investigators across the state. In order to obtain this exemption, the company must provide all the necessary information through the IND. There are two types of INDs:

  1. Commercial – For companies planning to obtain marketing approval for a new drug
  2. Research (Non-commercial) – For companies filing Investigator IND, Emergency Use IND, and Treatment IND

An IND and Information Sections

The information of the IND can be categorized into three broad areas:

  1. Animal Pharmacology and Toxicology Studies – This section contains all the information deemed necessary to ensure that the drug is safe for initial human testing. It also includes any previous history of use of the drug on humans.
  2. Manufacturing Information – This section contains information that ensures the capability of the manufacturing unit for producing adequate batches of the drug.
  3. Clinical Protocols and Investigator Information – This section contains information to identify if the initial tests could pose a risk to human.

New Drug Application (NDA)

For any drug to obtain approval for sales and marketing in the U.S., the manufacturer must submit a New Drug Application (NDA). It is a comprehensive document with 15 sections that provides data on animal and human studies, pharmacology of the drug, toxicology, and dosage, and contains information about the drug’s manufacturing process. The purpose of an NDA is to provide the FDA reviewer adequate data to ensure the safety and efficacy of the drug, labeling, and manufacturing process. Once submitted, the FDA takes 60 days to decide whether to review the application or reject it, due to missing information.

Once the FDA has reviewed the NDA, it issues one of the below mentioned three action letters:

  • Approval Letter – Indicates that the drug is approved
  • Approvable Letter – Indicates that the drug will be approved eventually, but requires rectification due to a few inadequacies such as labeling changes
  • Not Approvable Letter – Indicates that the drug cannot be approved with a list of supporting reasons

Both the applications IND and NDA are necessary to obtain market approval for a new drug product in the USA. Hence, authoring them with precision should be a high priority for manufacturers who are willing to enter the market in a quick and compliant way. Are you researching about any investigational drug and looking for Regulatory assistance in authoring compliant INDs and NDAs? Reach out to Freyr at sales@freyrsolutions.com.