New Drug Application in pharmaceutical

"New Drug Application (NDA) in pharmaceutical"

NDA in pharmaceutical

1. Background of NDA in pharmaceuticals?

NDA: New Drug Application 

      Since 1938, to commercialize the new product into market every drug has been approved through the FDA in the US subjects for the US. First makers have to take investigational new drug (IND) designation. The NDA application is a channel for the manufacturer to sell or commercialize the product into the US market. In NDA consist of data of preclinical study on animals and clinical trial on human. The NDA is based combination of in-vivo and in-vitro study.

2. What is NDA in pharmaceutical?

NDA (New Drug Application) is an application or request to FDA for approval of a new drug product for market commercialization. 

3. What is the goal of NDA?

The manufactured drug has to provide safety and effectiveness to the human being for it's intended proposed use and to assure the quality, strength, Identity, and purity of the drug product.

4. What are the Stages Involved in NDA?

• Preclinical trial on animals 
• Clinical trial ( phase 1,2,3,4)
• NDA submission
• NDA review
• NDA approval or rejection
• Follow up

Preclinical trial: 
       The preclinical trial includes the study on animals to get the exact information of the drug behavior and its criticality.

Clinical trial:
       A clinical trial is conducted on the human which includes four phases in that phase one study is about to safety for a human being. The second is about to effectiveness of the drug.third is about to adverse reaction of the drug and fourth is about to safety and efficacy of the drug.

NDA submission:
        After completion of the preclinical study and clinical trial the document is submitted to FDA in paper format or electronic format (Common technical document- CTD). Here CDER provides guidance to prepare NDA's.

NDA review:
         Once data submitted to the FDA, the FDA reviewer will review the data and give the opinion for approval or rejection to CDER.

NDA Approval/rejection:
          FDA reviewer will submit his review report and after studying the drug purpose, it's safety, efficacy, quality, and strength manufacturing site will get NDA approval or rejection from the FDA.

Follow up: 
          After approval of the drug, manufacturing companies will make drugs for human consumption. once drugs came into market the follow up is a must to know the drug safety, quality, and effectiveness, and on the basis of follow up, makers can continue the testing of the drug.

Clinical trial

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