Overview: What is 505 (b)(2)? Established under the Hatch-Waxman Amendments of 1984 to the Federal Food, Drug, and Cosmetic Act, the 505(b)(2) pathway expressly permits

Overview : FDA encourages sponsors to consult the agency during their products’ development program through one of its 3 types of formal meeting (Type A,

What is SAKIGAKE Designation? Overview: PMDA created a new regulatory pathway known as “SAKIGAKE” that allows the accelerated approval of drugs designated as breakthrough therapies

Overview:  The concept of substantial equivalence of medical devices was introduced bythe US Food and Drug Administration (FDA) as part of the Medical DevicesAmendment (MDA)