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Why 505(b)(2) is a Whole Different Animal

The three pathways to gain approval to market a drug in the United States share many common characteristics, but each is distinctly different from the others. It’s important to know in advance the strengths and weaknesses of each approach when considering a development strategy.

In broad terms, the 505(b)(1), 505(b)(2), and 505(j) approval pathways share the same requirements for FDA approval. However, the three pathways differ with respect to the amount of information the sponsor must provide from its own research. A 505(b)(2) application is one for which one or more of the studies relied upon for approval has not been conducted by or for the applicant. In these cases, an applicant may rely on published literature or on the FDA’s previous finding of safety and/or effectiveness for the drug. The 505(b)(2) pathway can offer important advantages for various types of drug manufacturers in an era of increased competitive pressure.

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