Situated between the NDA and the ANDA, a 505(b)(2) application is a type of US New Drug Application (NDA) that contains full reports of investigations of safety and effectiveness, but 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.
Source: U.S. FDA (www.fda.gov)
The 505(b)(2) application pathway was created in 1984 as part of the Hatch-Waxman Act, as it has become known, in order to rectify the scarcity of generic approvals in the U.S. at the time. [Its official name is the Drug Price Competition and Patent Term Restoration Act, which created new sections of the Federal Food, Drug and Cosmetic Act.].
Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (The “Hatch-Waxman” act) was created to simplify and speed up the approval process for drugs incorporating pharmacological agents which have already received approval. In such cases, the FDA application relies on clinical data previously submitted by others.
The intent of the 505(b)(2) pathway was to speed up the FDA application & review process and encourage further innovation with already- approved chemical entities by eliminating the need to duplicate, previously performed work.
Using a 505(b)(2) filing, companies and organizations can reference existing data and studies. This is done in consultation with the FDA. The 505(b)(2) approval process can lower risks (e.g., clinical and regulatory) while accelerating development and commercialization.
We’ve been working with clients for years on 505(b)(2) programs. At present, we are supporting over 120 API programs utilizing the 505(b)(2) pathway.