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New Drug Application (NDA)

A New Drug Application (NDA) is a document filed with the FDA in order to obtain approval for the marketing of a new drug.
New Drug Application (NDA) are the documents about the product you want to manufacture and those are submitted to the government to detail the product and its usage. This document may take months to years to be approved, so it is important to submit the correct NDA for approval.

What is NDA?

If you want to market a new drug in the United States, it is required to submit a New Drug Application (NDA). NDA application is submitted to FDA and it takes several months for approval. During this time FDA reviews the application and confirms that it is complete and meets their requirements. Drug developers can start clinical trials after the NDA is accepted by the FDA. If everything remains fine then drug products will be available in the market in the near future.

How to Apply for NDA?

There are a few things to know if you are applying for a New Drug Application (NDA). The application process is complicated and lengthy but a qualified consultant can help to apply successfully. Following are some tips for applying for an NDA.

1. Start the process of finding a qualified consultant. A consultant will help you to follow the process step by step and answer the questions you may have during the whole application process.

2. Before submission, make sure that the application is complete and accurate. Incorrect and misleading information can lead to delay or rejection of application.

3. Write a letter to FDA to request an early decision on your application. This will tell FDA that your application is complete and ready for review. This early decision request will reduce your waiting period to get a response from the FDA.

4. Be prepared to pay for an expert assistance that is required in most of the cases. The application process for NDA is expensive and you can save money by hiring a consultant.

What are the requirements for a New Drug Application?

A New Drug Application is a document filed to the Food and Drug Administration (FDA) to get approval for the marketing of new drugs in the United States. The application must include information about the drug product, details about the manufacturing company and the research done to develop the drug product. All the documents must be duly signed by the representative authorized by the company.

The application should be submitted in duplicate and each copy should be marked with the date of receipt. The application must have a drug study prospectus that explains the research done to develop a new drug. The application must be written in English language and must be signed by the representative authorized by the company.

Benefits of New Drug Application

A New Drug Application is submitted to the FDA when any company wants to bring a new drug in the market. The purpose of the submission of the NDA is to get approval for the marketing of the new drug in the US market.

There are many benefits of submitting a new drug application for FDA approval, some of these include:

1. Safety and Efficacy of Drug: It will help the manufacturer and consumer to gain certainty about the safety of the drug because the FDA conducts extensive testing before approval of the drug.

2. Preventing others the Producing or Selling the Same Product: if a competitor of any company knows about the pending approval of a New Drug Application, he may develop the same product and bring it into the market before the original product. An early submission of NDA companies can keep their competitors away and ensure their product will be the first in the market.

3. Protecting the Intellectual Property: By filling NDA any company can ensure that their invention can’t be stolen by their competitors. This protects the drug creators both financially and legally and they will have ownership of their creation.

What is the cost of NDA submission?

The cost of New Drug Application submission depends upon the complexity of the drug and the size of the company. But the average cost of a small company is around $1,00,000 while for a large company, it could be $2 million. There are some other costs like payments for experts to review NDA and costs paid for drug trials.

How much time it will take for the FDA to review an NDA?

The time taken by the FDA to review an NDA depends upon the type of the NDA submitted. Generally, it takes six months after the submission of the NDA. Sometimes this time may be longer than expected when NDA has some novel scientific information or the FDA has any questions about the safety and efficacy of the drug. A notification of compliance (NOC) has to be submitted by the applicant after acceptance of the NDA by the FDA. NOC has the data supporting the safety and efficacy of the drug product. The applicant has 30 days to submit the final NOC. If any changes are made in the NDA after submission, then a new NOC must be submitted.

When a new drug is invented by the company, a New Drug Application (NDA) is submitted to the FDA to get approval to market the new drug product. An NDA has detailed information about the company and the product including the mode of action, safety and efficacy, toxicology data and clinical trials. If everything goes right with the FDA review process, an NDA becomes a patent that will be the intellectual property of the drug developer company.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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