Guide on What exactly is a 505(b)(2) and its purpose

An accelerated New Drug Application (NDA) procedure in which the applicant relies on one or more studies done by someone other than the applicant and for which the applicant has not received right of reference is referred to as the 505(b)(2) New Drug Application (NDA). To put it another way, the 505(b)(2) route allows investigators and/or manufacturers to apply for approval without having to duplicate all of the drug research work that was done for an innovative medication.

There are three FDA drug approval procedures for new drug applications (NDA) and abbreviated new drug applications. The 505(b)(1) application is a complete NDA application. In the 505(b)(1) route, research is carried out by and for the sponsor, and the results are the main sources of information utilized to get FDA approval for a new medicine that will be used by patients in the United States. The 505(b)(1) method is the most time-consuming and resource-intensive of the three options.

It is necessary to file a 505(j) ANDA application to authorize a generic version of a medicine that is currently available on the market when the innovator drug's patent expiry date is approaching. The most important criteria for an ANDA are proof of bioequivalence (BE) vs the innovator product and, if the new medication is an oral dosage form, a food impact study, which is normally required.

For several reasons, the 505(b)(2) method may be beneficial to pharmaceutical businesses. This route may save some of the money and time that would otherwise be spent on the standard complete NDA route. The 505(b)(2) method may also remove the necessity for the majority of nonclinical studies as well as thorough safety and effectiveness evaluations, which are now required. Other advantages may include the following:

It is critical to identify medicinal items that are acceptable for the 505(b)(2) procedure as a first step in reducing the chance of failure and taking advantage of this more simplified path to approval. The pharmacokinetic profile of the new product should be at least as favourable as that of the innovator product, taking into account the planned application of the new product.

Report this Page