BLA Vs NDA

I am making small presentation on the topic FDA and came to heard about the two terms BLA and NDA related to FDA. Will you please provide me all details related to this and also provide me difference between BLA vs NDA so that I can put it on my presentation?

[Kiran Chandar]

As per your request here I am providing you the details about NDA and BLA. Please check the below details:

About NDA:

When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA).

The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics.

If the NDA is approved, the product may be marketed in the United States.

For internal tracking purposes, all NDA's are assigned an NDA number.

About BLA:

Biologic License Application (BLA)

Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act.

The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product.

A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product.

If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product

Other types of FDA Applications are:

Investigational New Drug (IND)
Abbreviated New Drug Application (ANDA)
Over-the-Counter Drugs (OTC)