505(b)(2) - The New Regulatory Pathway for NDA

What is 505(b)(2)?

To properly understand the meaning of 505(b)(2), we first need to understand the concept of a New Drug Application (NDA). NDA, in simple terms, means an application that has been proposed by a drug developer in front of the FDA (Food and Drug Administration) in the US for getting approval to sell the new drug in the market. After getting the permission, the applicant is authorized to sell it to the public. To make the process of authorization of new drugs more efficient and streamlined, 505(b)(2) was introduced by the Hatch-Waxman amendment in 1984. It is one of the three regulatory pathways for the approval of NDAs in the FDA.

The Purpose of 505(b)(2)

The main purpose behind the introduction of 505(b)(2) was to make the process of approval of NDAs faster and avoid the duplication of the research in the process. The pathway is used for the approval of a variety of drugs. Some of them are as follows:

DESI (Drug Efficacy Study Implementation) drugs
Orphan drugs
Prodrugs of an existing drug
Branded Generics
Drug-device combinations

Significance of 505(b)(2

The 505(b)(2) pathway was created by incorporating the elements of the other two pathways, namely, NDA 505(B)(1) and ANDA 505(j). The 505(b)(2) NDA is usually reserved for the cases where major changes are made to an existing drug which ultimately leads to the creation of a completely new drug product. This pathway overcomes certain limitations of the traditional NDA. Besides time and cost-saving benefits, it also reduces the risk of losing an investor can face in the development stage. The pathway also can give exclusive market rights of 3-7 years to the drug sponsor. In addition to all these, it also minimizes the need for conducting reports regarding the drug.

The NDA 505(b)(2) Approval Process

The whole process of getting approval of the new drug can be summarized under the following four major steps-

1. Identifying the Candidate

The process begins with the identification of a prospective drug. To be called an ideal candidate, the drug product should have the least development risk involved and great profit potential.

2. Candidate Assessment

A proper assessment of the candidate is done before the development stage to eliminate the risk of errors. The candidate is assessed under the heads of scientific, regulatory, medical and commercial viability.

3. Developing Product Plan

As the candidate is a “modified” product and not a newly created product, the company takes guidance from the FDA's previous findings and reports. The drug developer often tries to merge these data into the product’s development strategy. Besides this, the product also gets exclusive marketing rights at this stage.

4. Pre-IND Meeting

The process of pre-IND of the 505(b)(2) pathway is very different from that of the 505(b)(1) pathway. This stage focuses on developing concurrency with the Chemistry, Manufacturing and Controls (CMC) strategy. This will help the drug promoter to perform fewer tests for approval.

Conclusion

We can conclude that 505(b)(2) has successfully provided great opportunities for several famous drugs like aspirin- omeprazole, uridine- triacetate, ondansetron, etc. The pathway is very flexible and can adapt in the future according to the situations.

Source: https://pharmaceuticaldevelopmentgroup.medium.com/505-b-2-the-new-r...