Search Results - subject_exact:"Arzneimittelrecht"

Therapeutic substitutability under scrutiny : defining relevant markets in EU pharmaceutical law

Kaushik, Kanika - 2026

Market definition is fundamental to EU competition law. It serves as a preliminary step in assessing dominance, anti-competitive conduct, and merger control. With respect to the pharmaceutical sector, traditional approaches to defining the relevant market face specific hurdles. Therapeutic...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015638991

Timely access to new pharmaceuticals in Canada, the United States, and the European Union, 2026

Acri, Kristina M. L.; Assad, Lauren - 2026

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015613516

Aushandlung und Nutzen einer Grundsatzentscheidung nach Abs. 31 ArzneimittelDV

Weerth, Carsten - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015549664

Can the size and duration of clinical trials in new drug applications predict post-approval safety warnings?

Clark, Jeremy; Menclova, Andrea Kutinova - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015394355

Pharmaceutical regulation and incentives for innovation in an international perspective

Dubois, Pierre - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015466930

Evaluating quality reward and other interventions to mitigate US drug shortages

Naumov, Sergey; Noh, In Joon; Zhao, Hui - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015376804

Assessing consumers' valuation for Front-of-Package "health" labeling under FDA guidelines

Liu, Jianhui; Kassas, Bachir; Lai, John; Fang, Di; … - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015559479

Arzneimittelwirkstoffe in Nahrungs- und Nahrungsergänzungsmitteln

Weerth, Carsten - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015371270

Cost benefit analysis and the FDA : measuring the costs and benefits of drug approval under the PDUFA I-II : 1998-2005

DeCanio, Samuel - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015123272

The design of external reference pricing schemes and the choice of reference countries and pricing rules

Birg, Laura - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015166890

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The Design of External Reference Pricing Schemes and the Choice of Reference Countries and Pricing Rules

Birg, Laura - 2018

Book / Working Paper

Impact of hospital decision-making on drug markets : the case of biosimilars

Kanazawa, Kyogo - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015051304

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

Michaeli, Daniel; Michaeli, Christoph T.; Albers, Sebastian - 2024

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 track, accelerated approval, priority review, and...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015131485

When citizens legalize drugs

Lucchese, Elena; Roberti, Paolo - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015421066

From Free Rider to Innovator : The Rise of China's Drug Development

Barwick, Panle Jia; Xia, Hongyuan; Xia, Tianli - 2026

This paper examines China's transition from pharmaceutical "free rider" to global innovator over the last decade. In 2010, China accounted for less than 8% of global clinical trials; by 2020, it had surpassed the US in annual registered clinical trial volume. To study this transformation, we...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015626306

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From free rider to innovator : the rise of China's drug development

Barwick, Panle Jia; Xia, Hongyuan; Xia, Tianli - 2026

Book / Working Paper

The effect of salience on the equity market reaction to innovation announcements : theory and evidence from patent grants and FDA drug approvals

Chemmanur, Thomas J.; Li, Dongmei; Tseng, Kevin; Wang, Yu - 2026

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015660352

Effect of resource allocation on pharmaceutical firm profitability in the Indian market

Shenbagavalli, T.; Sathyanarayana, N.; Rajest, S. Suman; … - 2026

Persistent link: https://ebvufind01.dmz1.zbw.eu/10016061241

From black to grey : improving access to antimalarial drugs in the presence of counterfeits

Ding, Jiatao; Freeman, Michael; Zorc, Sasa - 2023

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014248204

Has the COVID-19 Crisis Affected the Growth of United States Food and Drug Administration Drug Approvals? The Answer Is not Yet! a Time Series (Forecasting) Study

Daizadeh, Iraj - 2023

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-19; HCoV-19; COVID-19) has affected all daily activities. Has it also affected the number of United States (FDA) drug approvals over time? The short answer from empirical time series forecasting is not yet. Care should be taken as the crisis...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014261986

A Safety-First Drug Approval Sequence Leads to Drugs That Are Less Safe and More Efficacious

Waters, James - 2023

The clinical stage of drug approval processes commonly starts with a safety test, and if it is successful, efficacy and further safety tests follow. This paper examines how the sequence of these tests affects pharmaceutical companies’ choice of drugs to develop. The safety-first testing...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014348351

Waiting for new medicines : how does Canada compare to the United States and Europe?

Rawson, Nigel S. B. - 2023

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014282191

Strategic submissions: a cross-country analysis of supplemental drug approvals

Dubois, Pierre; Gentry, Elissa Philip; Tuncel, Tuba - 2023

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014326955

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Strategic submissions : a cross-country analysis of supplemental drug approvals

Dubois, Pierre; Gentry, Elissa Philip; Tunçel, Tuba - 2023

Book / Working Paper

Resilient drug economy and politicised control : the rise and fall of the administrative bureau of prohibited drugs in China, 1922-1925

Huang, Yun - 2023

This paper examines the rise and fall of the Administrative Bureau of Prohibited Drugs in 1920s Shanghai. It identifies the factors associated with the endeavours of the central government to experiment with establishing a Bureau dedicated to regulating refined drugs and the reasons why the...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014443202

Drug shortages : empirical evidence from France

Dubois, Pierre; Majewska, Gosia; Reig, Valentina - 2023

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014229927

Impact of hospital-physician vertical integration on physician-administered drug spending and utilization

Levin, Jonathan S.; Zhao, Xiaoxi; Whaley, Christopher - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015358479

Die nutzenbasierte Preisbildung bei Arzneimitteln mit neuen Wirkstoffen : eine rechtswissenschaftliche Untersuchung von Mischpreisen im AMNOG-System

Westermann, Maren - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015329108

Supply-Side Opioid Restrictions and the Retail Pharmacy Market

Burton, Anne M.; Churchill, Brandyn F. - 2025

While policymakers routinely limit the sale of goods thought to be of risk to public health, relatively less is known about whether and how these policies affect firm performance. Using 2000-2018 National Establishment Time-Series data and a difference-in-differences strategy, we show that state...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015464449

Obligatory responses to FDA inspection outcomes and future drug shortages

Wang, Yixin; Ball, George; Anand, Gopesh; Park, Hyunwoo - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015432960

Should we prevent off-label drug prescriptions? : empirical evidence from France

Tunçel, Tuba - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015458894

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Should we prevent off-label drug prescriptions? : empirical evidence from France

Tunçel, Tuba - 2022

Book / Working Paper

Trials Avoid High Risk Patients and Underestimate Drug Harms

Abaluck, Jason; Agha, Leila; Shah, Sachin - 2025

The FDA does not formally regulate representativeness, but if trials under-enroll vulnerable patients, the resulting evidence may understate harm from drugs. We study the relationship between trial participation and the risk of drug-induced adverse events for cancer medications using data from...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015560660

Patents, innovation, and competition in pharmaceuticals : the Hatch-Waxman Act after 40 years

Hemphill, C. Scott; Sampat, Bhaven N. - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015404473

Lessons for the United States from pharmaceutical regulation abroad

Kyle, Margaret K. - 2025

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015404474

Investing in ex ante regulation : evidence from pharmaceutical patent examination

Frakes, Michael; Wasserman, Melissa F. - 2023

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014340794

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Investing in ex ante regulation : evidence from pharmaceutical patent examination

Frakes, Michael; Wasserman, Melissa F. - 2020

Book / Working Paper

Investing in Ex Ante Regulation : Evidence from Pharmaceutical Patent Examination

Frakes, Michael; Wasserman, Melissa F. - 2022

Book / Working Paper

Investing in Ex Ante Regulation : Evidence from Pharmaceutical Patent Examination

Frakes, Michael - 2020

Book / Working Paper

Cardiovascular drug shortages in Lebanon : a broken heart

Khattar, Georges; Hallit, Jennifer; El Chamieh, Carolla; … - 2022

For nearly 3 years now, Lebanon has been assailed by compounded crises. With the economic instability, the coronavirus pandemic, and the explosion of the Beirut Port on August 4, 2020; the fragile Lebanese healthcare system has found itself at massive risk of a catastrophic public health crisis...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10013198765

Bargaining and international reference pricing in the pharmaceutical industry

Dubois, Pierre; Gandhi, Ashvin; Vasserman, Shoshana - 2022

Persistent link: https://ebvufind01.dmz1.zbw.eu/10013202874

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Bargaining and International Reference Pricing in the Pharmaceutical Industry

Dubois, Pierre; Gandhi, Ashvin; Vasserman, Shoshana - 2022

Book / Working Paper

Bargaining and international reference pricing in the pharmaceutical industry

Dubois, Pierre; Gandhi, Ashvin; Vasserman, Shoshana - 2022

Book / Working Paper

Future-proofing pharmaceutical legislation : study on medicine shortages : country fiches

2022

Persistent link: https://ebvufind01.dmz1.zbw.eu/10013345656

Reverse drug distribution chain : analysis of the phenomenon

Bańska, Karolina; Furtak-Niczyporuk, Marzena; Dreher, … - 2022

Persistent link: https://ebvufind01.dmz1.zbw.eu/10013531967

Dangerous Prescribing and Healthcare Fragmentation : Evidence from Opioids

Ericson, Keith M. Marzilli; Sacarny, Adam; Zhou, R. Annetta - 2022

Fragmented healthcare received from many different physicians results in higher costs and lower quality, but does it contribute to dangerous opioid prescribing? The effect is theoretically ambiguous because fragmentation can trigger costly coordination failures but also permits greater...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10013191086

Assessing the Safety and Efficacy of the Fda : The Case of the Prescription Drug User Fee Acts

Philipson, Tomas J.; Berndt, Ernst R.; Gottschalk, Adrian; … - 2022

The US Food and drug Administration (FDA) is estimated to regulate markets accounting for about 20% of consumer spending in the US. This paper proposes a general methodology to evaluate FDA policies, in general, and the central speed-safety tradeoff it faces, in particular. We apply this...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10013308499

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Assessing the Safety and Efficacy of the FDA : The Case of the Prescription Drug User Fee Acts

Philipson, Tomas J. - 2005

Book / Working Paper

Internal deadlines, drug approvals, and safety problems

Cohen, Lauren; Gurun, Umit G.; Li, Danielle - 2021

Persistent link: https://ebvufind01.dmz1.zbw.eu/10012505032

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Internal deadlines, drug approvals, and safety problems

Cohen, Lauren; Gurun, Umit G.; Li, Danielle - 2020

Book / Working Paper

Internal Deadlines, Drug Approvals, and Safety Problems

Cohen, Lauren; Gurun, Umit G.; Li, Danielle - 2022

Book / Working Paper

Internal Deadlines, Drug Approvals, and Safety Problems

Cohen, Lauren - 2020

Book / Working Paper

Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation : evaluation report

2022

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014267126

Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation : analytical report

2022

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014267128

Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation : impact assessment report

2022

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014267130

Regulatory Incentives for Innovation : The FDA's Breakthrough Therapy Designation

Chandra, Amitabh; Kao, Jennifer L.; Miller, Kathleen; … - 2022

Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to innovate around this...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014240778

Innovation Adoption by Committee : Evaluating Decision-Making in the FDA

Canen, Nathan J.; Iaryczower, Matiás - 2024

The FDA is responsible for the approval of new drugs, biological products and medical devices in the United States. As part of the approval process, the FDA relies on advisory committees, which provide independent advice from outside experts. We combine a structural approach with newly collected...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015056111

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Innovation adoption by committee : evaluating decision-making in the FDA

Canen, Nathan; Iaryczower, Matiás - 2024

Book / Working Paper

Regulating ethical experimentation : impacts of the breakthrough therapy designation on drug R&D

Hermosilla, Manuel - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10014549760

Informed options trading before FDA drug advisory meetings

Wu, Zekun; Borochin, Paul; Golec, Joseph - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015069855

Generic drug shortages and undifferentiated competition

Choi, Seung-chan - 2024

Persistent link: https://ebvufind01.dmz1.zbw.eu/10015077056

Versorgungspolitische und gesundheitsökonomische Aspekte zum Regulierungsstatus homöopathischer Arzneimittel

Bauer, Cosima; Giulini-Limbach, Chiara; May, Uwe; … - 2021

Persistent link: https://ebvufind01.dmz1.zbw.eu/10012592011

FDA approval announcements : attention-grabbing or event-day misspecification?

Hamill, Philip A.; Hutchinson, Mark; Quang Minh Nhi Nguyen - 2018

Persistent link: https://ebvufind01.dmz1.zbw.eu/10012019644

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FDA approval announcements : Attention-grabbing or Event-day misspecification?

Hamill, Philip A.; Hutchinson, Mark; Quang Minh Nhi Nguyen - 2021

Book / Working Paper

Peltzman Revisited : Quantifying 21st Century Opportunity Costs of FDA Regulation

Mulligan, Casey B. - 2021

This paper revisits Peltzman (1973) in light of two recent opportunities to quantitatively assess tradeoffs in drug regulation. First, reduced regulatory barriers to drug manufacturing associated with the 2017 reauthorization of Generic Drug User Fee Amendments were followed by significantly...

Persistent link: https://ebvufind01.dmz1.zbw.eu/10012794602

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Peltzman Revisited : Quantifying 21st Century Opportunity Costs of FDA Regulation

Mulligan, Casey B. - 2021

Book / Working Paper