US FDA 505(b)(2) NDA clinical, CMC and regulatory strategy concepts to expedite drug development

Drug Discov Today. 2023 May 15:103618. doi: 10.1016/j.drudis.2023.103618. Online ahead of print.ABSTRACTThe 505(b)(2) NDA pathway can reduce drug development costs and accelerate the time to market by leveraging existing public data using clinical bridging and regulatory strategies. Whether or not a drug qualifies for the 505(b)(2) pathway depends on the active ingredient, drug formulation, clinical indication and other factors. Clinical programs can be streamlined and accelerated, and confer unique marketing benefits, such as exclusivity, depending on the regulatory strategy and product. Considerations for chemistry, manufacturing and controls (CMC) and the unique manufacturing issues that can arise owing to the accelerated development of 505(b)(2) drug products are also discussed. Teaser: New drug applications using the US FDA 505(b)(2) regulatory pathway can streamline and substantially reduce clinical drug development requirements, potentially obtaining marketing exclusivity and accelerating time to market.PMID:37196760 | DOI:10.1016/j.drudis.2023.103618
Source: Drug Discovery Today - Category: Drugs & Pharmacology Authors: Source Type: research