Search Results - subject:"Food and Drug Administration"

Special FDA designations for drug development : orphan, fast track, accelerated approval, priority review, and breakthrough therapy

Michaeli, Daniel; Michaeli, Christoph T.; Albers, Sebastian - In: The European journal of health economics 25 (2024) 6, pp. 979-997

Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and expedite drug …

Persistent link: https://www.econbiz.de/10015131485

Pharmocracy II : how corrupt deals and misguided medical regulations are bankrupting America - and what to do about it

Faloon, William - 2017

Persistent link: https://www.econbiz.de/10011657551

Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy

Michaeli, Daniel Tobias; Michaeli, Thomas; Albers, Sebastian - In: The European Journal of Health Economics 25 (2023) 6, pp. 979-997

Background: Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and …

Persistent link: https://www.econbiz.de/10015328830

Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy

Michaeli, Daniel Tobias; Michaeli, Thomas; Albers, Sebastian - In: The European Journal of Health Economics 25 (2023) 6, pp. 979-997

Background: Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and …

Persistent link: https://www.econbiz.de/10015404267

Food safety and imports : an analysis of FDA food-related import refusal reports

Buzby, Jean C.; Unnevehr, Laurian J.; Roberts, Donna H. - 2008

Persistent link: https://www.econbiz.de/10008667316

Assessing the safety and efficacy of the FDA : the case of the prescription drug user fee acts

Philipson, Tomas J.; Berndt, Ernst R.; Gottschalk, … - 2005

Persistent link: https://www.econbiz.de/10003193758

Opportunities for improving the drug development process : results from a survey of industry and the FDA

Berndt, Ernst R.; Gottschalk, Adrian H. B.; Strobeck, … - 2005

Persistent link: https://www.econbiz.de/10002945129

Structural topic modeling for corporate social responsibility of food supply chain management: evidence from FDA recalls on plant-based food products

An, Jiyoon - In: Social Responsibility Journal 20 (2024) 6, pp. 1089-1100

the food supply chain. This paper aims to investigate the recall of plant-based products with data from the US Food and … Drug Administration. Design/methodology/approach Introducing the structural topic modeling method allowed us to test …

Persistent link: https://www.econbiz.de/10015356382

Assessing the impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA approval process

Berndt, Ernst R.; Gottschalk, Adrian H. B.; Philipson, … - 2004

Persistent link: https://www.econbiz.de/10002379705

Using data science to find predictors of adverse regulatory inspections : enhancing quality risk management in the pharmaceutical industry

Eich, Steffen - 2021

Persistent link: https://www.econbiz.de/10013348655