Referencing A Listed Drug For The 505(b)(2) Pathway

By Kristen Leslie, PhD, Research Scientist, Camargo Pharmaceutical Services

Section 505(b)(2) of the Food, Drug, and Cosmetic Act describes a 505(b)(2) new drug application (NDA) as an application where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. This type of information can be sourced from the published literature (for more details, see our previous blog posts here and here) and/or from the Agency’s findings of safety and efficacy for a previously approved drug, or what is known as a listed drug (LD). The LD is defined in 21 CFR §314.3 as “a new drug product that has been approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act for safety and effectiveness or under section 505(j)(6) of the Federal Food, Drug, and Cosmetic Act, and which has not been withdrawn from sale for what FDA has determined are reasons of safety or effectiveness.”