NDA Submissions | 合法藥品大搜索

Because the FDA is an agency established by a federal law, there are clearly defined pathways along which a drug can be approved. Deciding on the appropriate regulatory pathway for your drug development program is a process that requires an understanding of the content and purposes of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.

The 505(b)(1) regulatory pathway is the traditional New Drug Application (NDA).  This pathway is used by sponsors to obtain the approval of a new drug whose active ingredients have not previously been approved.  As you can imagine, this type of submission requires extensive research including both clinical and nonclinical studies to prove the product’s safety and efficacy for the indication being sought.  Because of the substantial amount of research and data that is required, 505(b)(1) NDA submissions can take many years to complete, and req...