What is a 505b1 drug?
What is a 505b1 drug?
505 (b) (1): Traditional drug development via the 505 (b) (1) pathway is typically used for novel drugs that have not previously been studied or approved. 505 (b) (1) drug development requires the Sponsor to conduct all studies needed to demonstrate the safety and efficacy of the drug.
What is the difference between 505(b)(1) and 505(b)(2)?
505 (b) (2): The Hatch-Waxman Amendments of 1984 were designed to prevent the duplication of existing studies via the creation of the 505 (b) (2) pathway. A 505 (b) (2) program must demonstrate safety and efficacy to the same standards as a 505 (b) (1) program.
Can a 505(b)(2) product be met post-market?
Additionally, it is more likely that nonclinical and clinical commitments for a 505 (b) (2) product can be met post-market. A lack of familiarity with the nuances of the 505 (b) (2) pathway may also result in an unnecessarily larger development program than needed. How do we know this?
What is a 505(j) Anda?
505 (j) ANDA: Abbreviated new drug, or generic, approval requires a Sponsor to demonstrate bioequivalence to an innovator drug in lieu of replicating efficacy and safety studies.
