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Regulatory Incentives for Innovation : The FDA's Breakthrough Therapy Designation
Chandra, Amitabh; Kao, Jennifer L.; Miller, Kathleen L.; … - National Bureau of Economic Research - 2022
clinical trial design complexity. The results suggest that targeted regulatory innovation can shorten R&D periods without …
Persistent link: https://www.econbiz.de/10013477204
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The NBER Orange Book Dataset : A User's Guide
Durvasula, Maya; Hemphill, C. Scott; Ouellette, Lisa … - National Bureau of Economic Research - 2022
This paper introduces a newly digitized, open-access version of the Food and Drug Administration's "Orange Book"--a linkage between approved small-molecule drugs and the patents that protect them. The Orange Book also reports any applicable regulatory exclusivity that prevents competitive entry....
Persistent link: https://www.econbiz.de/10013462677
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Investigator Racial Diversity and Clinical Trial Participation
Alsan, Marcella; Campbell, Romaine A.; Leister, Lukas; … - National Bureau of Economic Research - 2023
We investigate whether increased racial diversity of clinical trial principal investigators could increase the enrollment of Black patients, which currently lags population and disease-burden shares. We conducted a survey experiment in which respondents were shown a photo of a current NIH...
Persistent link: https://www.econbiz.de/10014372489
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Improving Regulation for Innovation : Evidence from China's Pharmaceutical Industry
Jia, Ruixue; Ma, Xiao; Yang, Jianan; Zhang, Yiran - National Bureau of Economic Research - 2023
This study investigates how enhanced regulation can promote innovation, focusing on the impacts of a significant … recognized the improvement in drug innovation, as reflected in stock price adjustments post new drug registrations after the … latecomers could boost their innovation potential by adopting specific, effective regulatory practices from frontier countries …
Persistent link: https://www.econbiz.de/10014447297
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Fertility and Labor Market Responses to Reductions in Mortality
Bhalotra, Sonia R.; Venkataramani, Atheendar S.; … - National Bureau of Economic Research - 2022
We investigate women's fertility, labor and marriage market responses to a health innovation that led to reductions in …
Persistent link: https://www.econbiz.de/10013361971
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Can Operation Warp Speed Serve as a Model for Accelerating Innovations Beyond COVID Vaccines?
D'Souza, Arielle; Hoyt, Kendall; Snyder, Christopher M.; … - National Bureau of Economic Research - 2024
Operation Warp Speed (OWS) was a U.S. government-led program to accelerate the development, production, and administration of COVID-19 vaccines. The program cut the typical ten-year timeline needed to develop a new vaccine down to ten months and began vaccinating vulnerable populations within a...
Persistent link: https://www.econbiz.de/10015056157