The 505(b)(2) Application Mechanism Explained


The 505(b)(2) is a New Drug Application (NDA) mechanism which allows an applicant to seek approval for a drug product based on full safety and efficacy documentation, some of which may be from literature or conducted by others and for which the applicant does not have the right of reference.

Created in 1984, it is a streamlined process and does not require the applicant to conduct all the required studies or obtain a right of reference.

A 505(b)(2) can been used to get approvals for changes such as New Delivery Mechanisms, New Dosage Forms, New Formulations and New Indications. It has the advantage over the traditional process by being able to rely on previously published material, and so can be quicker as well as being lower cost

What is the 505(b)(2)?

A 505(b)(2) is a New Drug Application that can partially rely on the FDA’s previous approvals and published literature. It is described in section 505(b)(2) of the Federal Food, Drug and Cosmetic Act.


Benefits Of a 505(B)(2)

The intent of this pathway is to lower the cost of development, and speed approvals, and encourage innovation. For applicants this means:

• Lower costs compared to the traditional new drug approval process
• Faster approval times compared to the abbreviated new drug application (ANDA) or generic product approval process
• Longer market exclusivity (up to seven years in certain cases) compared to generic products
• Access to new markets and niches

Because of these benefits, 505(b)(2)s have become popular. The FDA approves twice as many 505(b)(2) applications as the 505(b)(1). They are projected to become increasingly widely used over the next few years, as the 505(b)(2) submission mechanism is one of the most useful approaches out of the FDA.

By leveraging the original 505(b)(1) or existing published literature, the FDA has given applicants a faster path to approval. Whether there is a “Eureka” around some aspect of a current drug product or an innovation for an existing product to pursue new markets, there is now a quicker way for submitting the proposed improvement.

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