Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy
DT Michaeli, T Michaeli, S Albers, T Boch… - The European Journal of …, 2024 - Springer
Background Over the past decades, US Congress enabled the US Food and Drug
Administration (FDA) to facilitate and expedite drug development for serious conditions …
Administration (FDA) to facilitate and expedite drug development for serious conditions …
Green financial regulation and shale gas resources management
Managing shale gas resources can cause environmental, safety, and other sustainability
issues. The Environment, Society, and Governance (ESG) report is seen as an important …
issues. The Environment, Society, and Governance (ESG) report is seen as an important …
Do investors value the FDA orphan drug designation?
KL Miller - Orphanet Journal of Rare Diseases, 2017 - Springer
Abstract Background The Orphan Drug Act is an important piece of legislation that uses
financial incentives to encourage the development of drugs that treat rare diseases. This …
financial incentives to encourage the development of drugs that treat rare diseases. This …
The signaling effects of incremental information: Evidence from stacked US Food and Drug Administration designations
Abstract The US Food and Drug Administration offers multiple designations for drugs under
development, such as the fast-track designation (for drugs that treat serious conditions with …
development, such as the fast-track designation (for drugs that treat serious conditions with …
[引用][C] MARKET RESPONSE TO ONCOLOGY RELATED CLINICAL TRIAL RESULT ANNOUNCEMENTS: AN EVENT STUDY ON THE US BIOPHARMACEUTICAL …
C Wilson - 2017 - University of Cape Town