505(b)(2) New Drug Application

A 505(b)(2) New Drug Application is a regulatory pathway used by pharmaceutical companies to get approval for a new drug. It allows the company to rely partly on existing scientific studies and FDA reviews of similar or previously approved drugs, rather than conducting all new clinical trials. This approach can save time and resources, especially when making modifications to an already approved medication, such as a new form, strength, or intended use. Essentially, it’s a streamlined process that leverages prior research to bring new or improved drugs to market efficiently.