FDA Guidance on ANDA and 505(b)(2) Applications

FDA issued guidance on May 9, 2019 for applicants submitting abbreviated approval marketing applications. The guidance was issued to assist applicants in determining which abbreviated approval pathway to choose under the Federal Food, Drug, and Cosmetic Act (FD&C Act): an abbreviated new drug application (ANDA) or a 505(b)(2) application.

The guidance details the criteria for submitting applications under the two pathways. It also provides considerations for determining the more appropriate application submitted under section 505(j) or pursuant to section 505(b)(2) of the FD&C Act. The guidance offers direction to potential applicants on requesting assistance from FDA in making this determination.

Specifically, the guidance discusses duplicate applications, petitioned ANDAs, and bundling of multiple products. Scientific considerations, such as types of studies and data, are discussed. API evaluations and formulation differences are also addressed.

Source: FDA