Similar Search Results

National Regulation and International Industry Structure in Pharmaceuticals

Roevekamp, Frank - 2011

industry activities proceeds, national regulation aimed at reducing costs for pharmaceuticals can have the unintended effect of …This paper looks into various means of regulating pharmaceuticals and their effects on the structure of the … international pharmaceutical industry. Regulation adds complexity to the activities of a firm. This complexity is multiplied, if …

Persistent link: https://www.econbiz.de/10013127115

Introduction to : FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

Lynch, Holly Fernandez; Cohen, I. Glenn - 2015

new problems and the improvements the agency can make to better serve the public good. It discusses effective regulation … transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. It …

Persistent link: https://www.econbiz.de/10014133445

Chapter Twelve. Markets for Pharmaceutical Products

Scott Morton, Fiona; Kyle, Margaret - In: Handbook of health economics : volume 2, (pp. 763-823). 2011

This chapter describes the market for pharmaceuticals, which exceeded $500 million in sales in 2010. The industry is … also characterized by extensive regulation of almost every activity, from product development through manufacturing and …

Persistent link: https://www.econbiz.de/10014025576

Parallel imports and manufacturer rebates : evidence from Germany

Birg, Laura - 2019

pharmaceuticals on competition by parallel imports. First, I analyze the effect of a manufacturer rebate on competition by parallel …

Persistent link: https://www.econbiz.de/10011949028

Is medicines parallel trade "regulatory arbitrage"?

Costa-Font, Joan - 2015

regulation, and not by price differences in line with the hypothesis of "regulatory arbitrage". …

Persistent link: https://www.econbiz.de/10010477153

Regulation of pharmaceutical prices : evidence from a reference price reform in Denmark ; conference paper

Kaiser, Ulrich; Méndez, Susan; Rønde, Thomas; … - 2013 - This version: February 23, 2013

Reference prices constitute a main determinant of patient health care reimbursement in many countries. We study the effects of a change from an "external" (based on a basket of prices in other countries) to an "internal" (based on comparable domestic products) reference price system. We find...

Persistent link: https://www.econbiz.de/10010339324

Harmonizing Race : Competing Regulatory Paradigms of Racial Categorization in International Drug Development

Kahn, Jonathan D. - 2013

particular, is opening up the large Japanese market to pharmaceuticals tested in the West. The FDA Guidance similarly promises to …

Persistent link: https://www.econbiz.de/10014053161

The New U.S. FDA Regulations on Biocompatibility and Reprocessing for Medical Devices

Reifschneider, Anna - 2018

In the past two years, the FDA has issued several important new guidances that radically altered the rules for medical device manufacturers on the inter-related topics of biocompatibility, reprocessing, and sterilization. This master’s thesis discusses various aspects of these policy changes...

Persistent link: https://www.econbiz.de/10014117060

The Shifting Functional Balance of Patents and Drug Regulation

Eisenberg, Rebecca S. - 2013

system and other regulation of drugs is more complex than this simple formulation suggests. Drug regulation operates in …

Persistent link: https://www.econbiz.de/10014126354

The Information Prescription for Drug Regulation

Bernstein, Anita; Bernstein, Joseph - 2013

Before it can sell a prescription drug lawfully in interstate commerce, a manufacturer must prove to the satisfaction of the Food and Drug Administration that the drug is both safe and effective. Congress approved this requirement in 1962 unanimously. Four decades of changes in the drug market...

Persistent link: https://www.econbiz.de/10014058315