The 505(b)(1) is a USFDA (United States Food and Drug Administration) Regulatory pathway traditionally known as New Drug Application (NDA). The Regulatory pathway is used to obtain approval for new drugs with previously unapproved active ingredients. These type of submissions require extensive research, whether clinical or non-clinical, to ensure product safety, which may take years to complete. This is one of the main reasons for which 505(b)(1) NDA submission takes longer to complete and a huge amount of resources for approval.

Any organization which opts for 505(b)(1) Regulatory pathway, should prepare an application comprising of all the necessary information related to the safety and quality of the new active ingredient. Since the process is time-consuming, information is collected based on the clinical studies conducted.


The 505(b)(2) is another USFDA Regulatory pathway for approving a new drug which has previously approved active ingredients. This Regulatory pathway is an alternative to NDA process and is for approval of applications containing investigations of safety reports which were not conducted by or for the sponsors. By following 505(b)(2), sponsors can completely rely on the data provided by other companies as they tend to avoid unnecessary duplication of the studies performed earlier. 505(b)(2) Regulatory pathway takes lesser time to complete than the 505(b)(1) Regulatory pathway as the data is of the existing reference drugs.

For any Regulatory pathway, the standards for approval is same, as all the NDAs must be evaluated based on the risk-benefit analysis. While deciding which Regulatory pathway is best for you, two things must be clear; firstly, if the product is a part of a New Chemical Entity (NCE) and secondly, if it is an existing product or a new formulation with any published literature. Addressing those questions will help to choose a Regulatory pathway which is best suited for your product.

The success of any submission is completely based on choosing the right Regulatory pathway. We at Freyr can help you achieve this, contact our experts at sales@freyrsolutions.com.