Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and expedite drug … development for serious conditions filling unmet medical needs with five special designations and review pathways: orphan, fast …

expedite drug development for serious conditions filling unmet medical needs with five special designations and review pathways …’s five special designations for drug development regarding their safety, efficacy/clinical benefit, clinical trials … market. However, faster drug development and regulatory review are associated with more unrecognized adverse events and post …

sufficient investment is left after mergers to further develop firms’ internal drug development capability. We evaluate the effects … of M&As on firms’ post-merger R&D investments and drug development capabilities across drug development phases. This study … effect on firms’ drug development at the late development phases through economies of scope. At the early development phases …

sufficient investment is left after mergers to further develop firms' internal drug development capability. We evaluate the … effects of M&As on firms' post-merger R&D investments and drug development capabilities across drug development phases. This … effect on firms' drug development at the late development phases through economies of scope. At the early development phases …

in various aspects. New drug development is becoming more complex, costly, and challenging. This paper examines how the … pharmaceutical value chain model could integrate with the product-life-cycle perspective to better explain the drug development … process changes and how the digital transformation could be implemented at each stage of the drug development process. We …