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The Global Entry of New Pharmaceuticals : A Joint Investigation of Launch Window and Price

Verniers, I. - 2012

) and launch price are interrelated and how regulation influences both launch window and launch price. The research context … increases with the price of the new drug. We also find that regulation overall increases the launch window, except for patent … protection. Surprisingly, regulation does not directly impact launch price. The descriptive information on average launch window …

Persistent link: https://www.econbiz.de/10013114669

Cross-National Evidence on Generic Pharmaceuticals : Pharmacy vs. Physician-Driven Markets

Danzon, Patricia M. - 2011

This paper examines the role of regulation and competition in generic markets. Generics offer large potential savings …

Persistent link: https://www.econbiz.de/10013122264

Regulating Risks in Pharmaceutical Law : The Need of an Optimal Interplay Between Products Safety and Products Liability

Rizzi, Marco - 2011

systems of regulation and liability operate complementarily. The question is why two legal tools that are meant to achieve and … between the two. At present we have two separate sets of rules that operate independently: pre-marketing regulation with post …

Persistent link: https://www.econbiz.de/10013124248

Drug Development - Stuck in a State of Puberty? : Regulatory Reform of Human Clinical Research to Raise Responsiveness to the Reality of Human Variability

Malinowski, Michael J. - 2012

about the sufficiency of FDA *364 regulation. This Article questions how prescription medicines reach the market and …

Persistent link: https://www.econbiz.de/10013098116

Effects of China's Pharmaceutical Price Regulation between 1997 and 2008

Wu, Binzhen - 2014

This paper uses macro-level data between 1997 and 2008 to evaluate the effects of China's pharmaceutical price regulations. We find that these regulations had short-run effects on medicine price indices, reducing them by less than 0.5 percentage points. The effects could have been slightly...

Persistent link: https://www.econbiz.de/10013066440

FDA Regulation of Biosimilars

Lietzan, Erika - 2015

The Biologics Price Competition and Innovation Act (BPCIA) was enacted in March 2010 as part of the Affordable Care Act (ACA). The objective of the BPCIA, like the Hatch-Waxman Amendments of 1984 for generic copies of non-biological drugs, was to increase price competition and generate cost...

Persistent link: https://www.econbiz.de/10013015283

Regulatory Malfunctions in the Drug Patent Ecosystem

Santos Rutschman, Ana - 2020

Persistent link: https://www.econbiz.de/10012835666

Systemic Failure of Regulation : The Political Economy of Pharmaceutical and Bulk Drug Manufacturing

Vijay, Gudavarthy - 2017

This chapter challenges the myth of pharmaceuticals constituting a Sun Rise industry of great potential for the future of the nation. This notion has come to assign a privileged status to such production, which in turn has contributed to regulatory agencies treating manufacturers as life-savers...

Persistent link: https://www.econbiz.de/10012962899

Food and Drug Law : Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Cosmetics, Veterinary and Tobacco Products Regulation

Termini, Roseann B. - 2019

This comprehensive food and drug law resource, “Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical … Devices, Foods, Dietary Supplements, Personal Care, Veterinary and Tobacco Products Regulation,” is organized for ease of … each subject based on regulation under the United States Federal Food, Drug and Cosmetic Act (FDCA) and related law. This …

Persistent link: https://www.econbiz.de/10012889695

The Determinants of Audit Delay and the Effects of Changes in Regulation on the Timeliness of Textile Industries and Pharmaceutical’s Financial Reporting : Bangladesh Perspective

Hossain, Md - 2019

Good accounting information is usually characterized by factors such as relevance, adequacy, Comparability and reliability in order for the information provided to be useful for decision making by the various stakeholders which include investors and government agencies. Before accounting...

Persistent link: https://www.econbiz.de/10012893840