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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.
