EconBiz - Find Economic Literature
    • Logout
    • Change account settings
  • A-Z
  • Beta
  • About EconBiz
  • News
  • Thesaurus (STW)
  • Academic Skills
  • Help
  •  My account 
    • Logout
    • Change account settings
  • Login
EconBiz - Find Economic Literature
Publications Events
Search options
Advanced Search history
My EconBiz
Favorites Loans Reservations Fines
    You are here:
  • Home
  • Search: subject_exact:"Arzneimittelrecht"
Narrow search

Narrow search

Year of publication
Subject
All
Arzneimittelrecht 731 Pharmaceutical law 555 Arzneimittel 320 Pharmaceuticals 304 Pharmaceutical industry 214 Pharmaindustrie 214 Arzneimittelmarkt 192 Pharmaceutical market 151 USA 136 United States 129 Deutschland 119 EU-Staaten 114 EU countries 111 Regulierung 90 Regulation 88 Germany 74 Pharmakologie 64 Drogenkonsum 63 Pharmacology 63 Drug consumption 61 Droge 49 Drug 49 Vereinigte Staaten 43 Welt 42 Wirkungsanalyse 39 Impact assessment 38 World 38 Drogenpolitik 36 Drug policy 31 Theorie 29 Cannabis 28 Gesundheitskosten 28 Gesundheitspolitik 28 Theory 28 Health care costs 27 EG-Staaten 26 Innovation 26 Pharmazeutische Industrie 26 Generika 23 Health policy 23
more ... less ...
Online availability
All
Free 202 Undetermined 66 CC license 6
Type of publication
All
Book / Working Paper 441 Article 287 Journal 3
Type of publication (narrower categories)
All
Article in journal 161 Aufsatz in Zeitschrift 161 Graue Literatur 104 Non-commercial literature 104 Working Paper 74 Arbeitspapier 69 Aufsatz im Buch 43 Book section 43 Amtsdruckschrift 42 Government document 42 Hochschulschrift 39 Thesis 22 Collection of articles of several authors 14 Sammelwerk 14 Conference paper 13 Konferenzbeitrag 13 Gesetz 11 Law 11 Konferenzschrift 9 Bibliografie enthalten 7 Bibliography included 7 Conference proceedings 7 Aufsatzsammlung 6 Forschungsbericht 6 Amtliche Publikation 5 Mehrbändiges Werk 5 Multi-volume publication 5 Article 4 Research Report 4 Advisory report 3 Case study 3 Dissertation u.a. Prüfungsschriften 3 Fallstudie 3 Gutachten 3 Bibliografie 1 Collection of articles written by one author 1 Glossar enthalten 1 Glossary included 1 Handbook 1 Handbuch 1
more ... less ...
Language
All
English 452 German 155 Undetermined 96 French 20 Swedish 7 Danish 2 Spanish 2 Italian 1 Dutch 1 Norwegian 1 Portuguese 1
more ... less ...
Author
All
Olson, Mary K. 14 Philipson, Tomas J. 14 Berndt, Ernst R. 10 Velásquez, Germán 9 Grabowski, Henry G. 8 Chatterjee, Chirantan 7 Sabia, Joseph J. 7 Bradford, W. David 6 Cassel, Dieter 6 Gottschalk, Adrian H. B. 6 Jørring, Adam 6 Kim, Yujin 6 Lo, Andrew W. 6 Singh, Manita 6 Strobeck, Matthew W. 6 Thakor, Richard T. 6 Vernon, John A. 6 Anderson, D. Mark 5 Dubois, Pierre 5 Evans, William N. 5 Golec, Joseph 5 Hansen, Benjamin 5 Higgins, Matthew J. 5 Li, Danielle 5 Nardinelli, Clark 5 Power, Patrick 5 Rees, Daniel I. 5 Wasem, Jürgen 5 Abbott, Frederick M. 4 Birg, Laura 4 Cohen, Lauren 4 Feick, Jürgen 4 Frakes, Michael 4 Greß, Stefan 4 Gurun, Umit G. 4 Law, Marc T. 4 Mulligan, Casey B. 4 Pacula, Rosalie Liccardo 4 Peltzman, Sam 4 Powell, David 4
more ... less ...
Institution
All
National Bureau of Economic Research 24 Europäische Kommission 22 European Commission / DG III - Industry 13 European Commission / Directorate-General for Health and Food Safety 7 Europäische Kommission / Generaldirektion Industrie, Arzneimittel und Kosmetika 6 Technopolis Group 6 Commission of the European Communities 4 Europäische Kommission / Generaldirektion Gesundheit und Lebensmittelsicherheit / Unit Medicines: Policy, Authorisation and Monitoring 4 Europäische Kommission / Referat Arzneimittel und Kosmetika 4 United States / Congress / House / Committee on Government Operations 4 American Enterprise Institute for Public Policy Research 2 Arbeitsgemeinschaft der Berufsvertretungen Deutscher Apotheker 2 Ecorys 2 Europäische Gemeinschaften / Kommission 2 Europäische Gemeinschaften / Rat 2 Europäische Kommission / Generaldirektion Industrie 2 Europäische Union / Rat 2 Europäisches Parlament 2 Food and Drug Administration 2 Milieu Ltd. 2 South Centre 2 Syndicat National de l'Industrie Pharmaceutique 2 Australien / Department of Health and Family Services 1 Australien / Parliament / House of Representatives / Standing Committee on Community Affairs 1 Board of Pharmacy 1 Books on Demand GmbH <Norderstedt> 1 Bundesärztekammer 1 Center for Health Policy Research 1 Center in Political Economy 1 Colloque de Droit Pharmaceutique <1984, Clermont-Ferrand> 1 Conference on International Harmonisation of Veterinary Medicinal Products <1, 1999, Brüssel> 1 Council of the European Union / General Secretariat of the Council 1 Dep. of Health, Education and Welfare 1 Deutsche Bundestag, 3. Wahlperiode, Ausschuss für Gesundheitswesen, Bonn 1 Deutscher Apothekerverband 1 Deutschland <Bundesrepublik> / Bundestag 1 Eastland subm. the report together with individual views (to accompany S. 1552) 1 Economic Cooperation Administration 1 Ecorys BV 1 Europa-Institut Freiburg 1
more ... less ...
Published in...
All
NBER working paper series 24 Working paper / National Bureau of Economic Research, Inc. 18 NBER Working Paper 16 The journal of law & economics 12 Journal of health economics 8 Kom / Kommission der Europäischen Gemeinschaften 8 Wettbewerb in Recht und Praxis : wrp 8 Document / Commission of the European Communities 7 Health economics 7 Dokument / Kommission der Europäischen Gemeinschaften 6 Entwicklung und Wandel in der Gesundheitspolitik : 20. Bad Orber Gespräche über kontroverse Themen im Gesundheitswesen 6 Journal of pharmaceutical finance, economics & policy 6 Amtsblatt der Europäischen Gemeinschaften 5 Pharma-Dialog 5 Revue du marché commun 5 Statens offentliga utredningar : SOU 5 The journal of law, economics, & organization 5 Discussion paper series / IZA 4 Dokument / Europäische Kommission 4 Journal of public policy & marketing : JPP & M ; an annual publ. of the Division of Research, Graduate School of Business Administration, University of Michigan 4 Neuerungen im Krankenhaus- und Arzneimittelbereich zwischen Bedarf und Finanzierung : 21. Bad Orber Gespräche über kontroverse Themen im Gesundheitswesen 4 Research Paper 4 Research papers / South Centre 4 Schriftenreihe des Zentrums für Europäische Rechtspolitik der Universität Bremen (ZERP) 4 Working papers / TSE : WP 4 Die Regelung der Arzneimittel in der Europäischen Gemeinschaft 3 Journal of illicit economies and development : JIED 3 Neue juristische Wochenschrift : NJW 3 Nordisk udredningsserie : NU 3 The American journal of economics and sociology 3 The facts about drug abuse 3 Working paper 3 Allokation im marktwirtschaftlichen System 2 Cege discussion paper 2 Contemporary economic policy : a journal of Western Economic Association International 2 Det Danske marked : organ for Instituttet for Salgsorganisation og Reklame og Presseforskningen ved Handelshøjskolen i København 2 Die Regelung der Arzneimittel in der Europäischen Union 2 Discussion papers / CEPR 2 Diskussionspapier / Institut für Medizinische Soziologie, Fachbereich Medizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main 2 Economic inquiry : journal of the Western Economic Association International 2
more ... less ...
Source
All
ECONIS (ZBW) 708 EconStor 13 USB Cologne (EcoSocSci) 10
Showing 1 - 50 of 731
Cover Image
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://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015394355
Saved in:
Cover Image
Evaluating quality reward and other interventions to mitigate US drug shortages
Naumov, Sergey; Noh, In Joon; Zhao, Hui - In: Journal of operations management 71 (2025) 3, pp. 335-372
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015376804
Saved in:
Cover Image
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 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://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015131485
Saved in:
Cover Image
Impact of hospital decision-making on drug markets : the case of biosimilars
Kanazawa, Kyogo - 2024
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015051304
Saved in:
Cover Image
Cost benefit analysis and the FDA : measuring the costs and benefits of drug approval under the PDUFA I-II : 1998-2005
DeCanio, Samuel - In: Journal of regulatory economics 66 (2024) 2/3, pp. 174-180
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015123272
Saved in:
Cover Image
Arzneimittelwirkstoffe in Nahrungs- und Nahrungsergänzungsmitteln
Weerth, Carsten - In: BDZ-Fachteil (2024) 11, pp. F79-F83
Zollbeamte müssen ein hohes Maß an Warenkunde beherrschen, um die vielfältigen Waren, die grenzüberschreitend gehandelt werden, zolltariflich, aber auch VuB-rechtlich einstufen zu können. Ein rechtlicher Grundsatz in Deutschland ist dabei: Es handelt sich entweder um ein Arzneimittel nach...
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015371270
Saved in:
Cover Image
When citizens legalize drugs
Lucchese, Elena; Roberti, Paolo - In: European journal of political economy 85 (2024), pp. 1-10
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015421066
Saved in:
Cover Image
Resilient drug economy and politicised control : the rise and fall of the administrative bureau of prohibited drugs in China, 1922-1925
Huang, Yun - In: Journal of illicit economies and development : JIED 5 (2023) 2, pp. 54-68
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://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014443202
Saved in:
Cover Image
Strategic submissions: a cross-country analysis of supplemental drug approvals
Dubois, Pierre; Gentry, Elissa Philip; Tuncel, Tuba - 2023
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014326955
Saved in:
Cover Image
From black to grey : improving access to antimalarial drugs in the presence of counterfeits
Ding, Jiatao; Freeman, Michael; Zorc, Sasa - 2023
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014248204
Saved in:
Cover Image
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://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014261986
Saved in:
Cover Image
Waiting for new medicines : how does Canada compare to the United States and Europe?
Rawson, Nigel S. B. - 2023
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014282191
Saved in:
Cover Image
Drug shortages : empirical evidence from France
Dubois, Pierre; Majewska, Gosia; Reig, Valentina - 2023
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014229927
Saved in:
Cover Image
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://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014348351
Saved in:
Cover Image
Impact of hospital-physician vertical integration on physician-administered drug spending and utilization
Levin, Jonathan S.; Zhao, Xiaoxi; Whaley, Christopher - In: Health economics 34 (2025) 2, pp. 345-367
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015358479
Saved in:
Cover Image
Patents, innovation, and competition in pharmaceuticals : the Hatch-Waxman Act after 40 years
Hemphill, C. Scott; Sampat, Bhaven N. - In: The journal of economic perspectives : a journal of the … 39 (2025) 2, pp. 27-52
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015404473
Saved in:
Cover Image
Lessons for the United States from pharmaceutical regulation abroad
Kyle, Margaret K. - In: The journal of economic perspectives : a journal of the … 39 (2025) 2, pp. 53-78
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015404474
Saved in:
Cover Image
Reverse drug distribution chain : analysis of the phenomenon
Bańska, Karolina; Furtak-Niczyporuk, Marzena; Dreher, … - In: European research studies 25 (2022) 2, pp. 94-103
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013531967
Saved in:
Cover Image
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://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014240778
Saved in:
Cover Image
Investing in Ex Ante Regulation : Evidence from Pharmaceutical Patent Examination
Frakes, Michael; Wasserman, Melissa F. - 2022
We explore how the Patent Office may improve the quality of issued patents on “secondary” drug features by giving examiners more time to review drug-patent applications. Our findings suggest that current time allocations are causing examiners to issue low quality secondary patents on the...
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013289805
Saved in:
Cover Image
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://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013308499
Saved in:
Cover Image
Should we prevent off-label drug prescriptions? : empirical evidence from France
Tunçel, Tuba - 2022
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013449336
Saved in:
Cover Image
Bargaining and international reference pricing in the pharmaceutical industry
Dubois, Pierre; Gandhi, Ashvin; Vasserman, Shoshana - 2022
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013202874
Saved in:
Cover Image
Bargaining and International Reference Pricing in the Pharmaceutical Industry
Dubois, Pierre; Gandhi, Ashvin; Vasserman, Shoshana - National Bureau of Economic Research - 2022
The United States spends twice as much per person on pharmaceuticals as European countries, in large part because prices are much higher in the US. This fact has led policymakers to consider legislation for price controls. This paper assesses the effects of a US international reference pricing...
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013210081
Saved in:
Cover Image
Dangerous Prescribing and Healthcare Fragmentation : Evidence from Opioids
Ericson, Keith M. Marzilli; Sacarny, Adam; Zhou, R. Annetta - National Bureau of Economic Research - 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://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013191086
Saved in:
Cover Image
Cardiovascular drug shortages in Lebanon : a broken heart
Khattar, Georges; Hallit, Jennifer; El Chamieh, Carolla; … - In: Health economics review 12 (2022) 1, pp. 1-2
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://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013198765
Saved in:
Cover Image
Internal Deadlines, Drug Approvals, and Safety Problems
Cohen, Lauren; Gurun, Umit G.; Li, Danielle - 2022
Absent explicit quotas, incentives, reporting, or fiscal year-end motives, drug approvals around the world surge in December, at month-ends, and before respective major national holidays. Drugs approved before these informal deadlines are associated with significantly more adverse effects,...
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014090782
Saved in:
Cover Image
Future-proofing pharmaceutical legislation : study on medicine shortages : country fiches
Technopolis Group; Ecorys; Milieu Ltd. - 2022
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013345656
Saved in:
Cover Image
Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation : evaluation report
Technopolis Group; Europäische Kommission / … - 2022
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014267126
Saved in:
Cover Image
Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation : analytical report
Technopolis Group; Europäische Kommission / … - 2022
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014267128
Saved in:
Cover Image
Study in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation : impact assessment report
Technopolis Group; Europäische Kommission / … - 2022
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014267130
Saved in:
Cover Image
Generic drug shortages and undifferentiated competition
Choi, Seung-chan - In: Advances in National Brand and Private Label Marketing …, (pp. 53-59). 2024
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015077056
Saved in:
Cover Image
Regulating ethical experimentation : impacts of the breakthrough therapy designation on drug R&D
Hermosilla, Manuel - In: Journal of health economics 94 (2024), pp. 1-26
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014549760
Saved in:
Cover Image
Innovation adoption by committee : evaluating decision-making in the FDA
Canen, Nathan; Iaryczower, Matiás - 2024
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015049943
Saved in:
Cover Image
Innovation Adoption by Committee : Evaluating Decision-Making in the FDA
Canen, Nathan J.; Iaryczower, Matiás - National Bureau of Economic Research - 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://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015056111
Saved in:
Cover Image
Informed options trading before FDA drug advisory meetings
Wu, Zekun; Borochin, Paul; Golec, Joseph - In: Journal of corporate finance 84 (2024), pp. 1-28
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015069855
Saved in:
Cover Image
Versorgungspolitische und gesundheitsökonomische Aspekte zum Regulierungsstatus homöopathischer Arzneimittel
Bauer, Cosima; Giulini-Limbach, Chiara; May, Uwe; … - 2021
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10012592011
Saved in:
Cover Image
The More Things Change : Improvement Patents, Drug Modifications, and the FDA
Karshtedt, Dmitry - 2021
Pharmaceutical companies often replace prescription drugs that are already on the market with modified versions that have the same active pharmaceutical ingredient. On the surface, such activity seems benign and perhaps even salutary. Nonetheless, antitrust litigation has revealed that firms...
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013224253
Saved in:
Cover Image
Informed Options Trading Before Fda Drug Advisory Committee Meetings
Wu, Zekun; Borochin, Paul; Golec, Joseph H. - 2021
The Food and Drug Administration uses committees of experts to evaluate potential new drugs. Weeks before they meet, the experts receive nonpublic reports from drug firms and FDA staff. We find significant abnormal options trading before meeting dates and report creation dates, particularly for...
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10014359294
Saved in:
Cover Image
Future-proofing pharmaceutical legislation : study on medicine shortages : executive summary
Jongh, Thyra de (contributor); Becker, Dominik (contributor) - European Commission / Directorate-General for Health …; … - 2021
Member States and many stakeholders, including pharmacy organisations, have signalled a rise in shortages of medicinal products in the European Union (EU). Shortages present a major problem for the quality and continuity of patient care. At best, patients can be provided with an equivalent...
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10015320647
Saved in:
Cover Image
Regulatory Reactivity in FDA's Approval of the Alzheimer's Disease Drug Aducanumab (Aduhelm)
Heled, Yaniv; Santos Rutschman, Ana; Vertinsky, Liza - 2021
On June 7, 2021, the U.S. Food and Drug Administration (FDA) approved aducanumab, a therapy for the treatment of Alzeihmer’s disease sponsored by Biogen and set to be commercialized under the brand name Aduhelm. Aduhelm was the first treatment for Alzeihmer’s approved by the FDA since 2003....
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013217118
Saved in:
Cover Image
Assessing the Impacts of the Prescription Drug User Fee Acts (Pdufa) on the Fda Approval Process
Berndt, Ernst R.; Gottschalk, Adrian; Philipson, Tomas J.; … - 2021
Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within specified time periods. In turn, the FDA was permitted to levy user fees on drug sponsors...
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013217967
Saved in:
Cover Image
FDA approval announcements : Attention-grabbing or Event-day misspecification?
Hamill, Philip A.; Hutchinson, Mark; Quang Minh Nhi Nguyen - 2021
The attention-grabbing hypothesis has been offered as a behavioural explanation for post-event abnormal returns for FDA drug approval announcements for NYSE listed firms. We show that when event-day mis-specification is accounted for the market reaction is centred on the event-day and that the...
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013231342
Saved in:
Cover Image
Regulatory Approval and Expanded Market Size
Berger, Benjamin; Chandra, Amitabh; Garthwaite, Craig - National Bureau of Economic Research - 2021
Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality certification. We combine data on...
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10012585373
Saved in:
Cover Image
Versorgungspolitische und gesundheitsökonomische Aspekte zum Regulierungsstatus homöopathischer Arzneimittel
Bauer, Cosima; Giulini-Limbach, Chiara; May, Uwe; … - 2021
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10012588364
Saved in:
Cover Image
Biosimilar Competition : Early Learning
Frank, Richard G.; Shahzad, Mahnum; Feldman, William B.; … - National Bureau of Economic Research - 2021
Biologics accounted for roughly $145 billion in spending in 2018 (IQVIA, 2019). They are also the fastest growing segment of the pharmaceutical industry. The Biological Price Competition and Innovation Act (BPCIA) of 2010 created an abbreviated pathway for biosimilar products to promote price...
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10012496071
Saved in:
Cover Image
Peltzman Revisited : Quantifying 21st Century Opportunity Costs of FDA Regulation
Mulligan, Casey B. - National Bureau of Economic Research - 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://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10012794602
Saved in:
Cover Image
Future-proofing pharmaceutical legislation : study on medicine shortages : final report
Technopolis Group; Ecorys; Milieu Ltd. - 2021 - revised
Persistent link: https://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10012806591
Saved in:
Cover Image
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, ebvufind01.dmz1.zbw.eu/10013348655
Saved in:
Cover Image
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://www.econbiz.de, ebvufind01.dmz1.zbw.eu/10013309998
Saved in:
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 9
  • 10
  • 11
  • Next
  • Last
A service of the
zbw
  • Sitemap
  • Plain language
  • Accessibility
  • Contact us
  • Imprint
  • Privacy

Loading...