What is 505(b)(1) & 505(b)(2)? NDA, NCE | 合法藥品大搜索

The 505(b)(1) is a USFDA (United States Food and Drug Administration) Regulatory pathway traditionally known as New Drug Application (NDA). The Regulatory pathway is used to obtain approval for new drugs with previously unapproved active ingredients. These type of submissions require extensive research, whether clinical or non-clinical, to ensure product safety, which may take years to complete. This is one of the main reasons for which 505(b)(1) NDA submission takes longer to complete and a huge amount of resources for approval.

Any organization which opts for 505(b)(1) Regulatory pathway, should prepare an application comprising of all the necessary information related to the safety and quality of the new active ingredient. Since the process is time-consuming, information is collected based on the clinical studies conducted.