What's a 505(b)(2)?

​There are three approval pathways by which drugs may gain approval through the U.S. Food and Drug Administration (FDA). The 505(b)(2) new drug application (NDA) is one of the three and was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a specific section of the U.S. Federal Food, Drug, and Cosmetic Act. 
The provisions of a 505(b)(2) provide manufacturers who have certain types of drugs with an opportunity to acquire FDA approval without performing all the work that’s required with a standard 505(b)(1) NDA.

505(b)(2) Development

A 505(b)(2) is not a generic application and offers advantages including market exclusivity. Let us help you determine the best  way to utilize this regulatory path. We can help you determine market opportunities, identify the right partners to create a viable product, and how to protect your product well into the future.

505(b)(2) Regulatory

 The 505(b)(2) Platform will help you understand how to develop the bioavailability bridge and demonstrate that reliance on the bridge is scientifically justified.  We can also assist with the writing preparing and publishing of your regulatory submissions.

505(b)(2) Commercial

Todays market requires a clear value proposition. The key to market success is engineering value into your product well before it enters the market. The 505(b)(2) Platform can help with sound commercial insight and early guidance. Become a member of The 505(b)(2) Platform today.

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