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high. Under current doctrine, a generic drugmaker is liable for induced infringement if its drug label so much as hints at … generic drug labels and in cases when only an in-depth inquiry into the language of the label might promote infringement. As I … because it unconstitutionally prolongs drug monopolies and undermines a key statutory path to generic competition. Revisiting …
Persistent link: https://www.econbiz.de/10013242386
In this paper, we argue that lower prices for pharmaceuticals can be achieved by fostering a new type of competition in … the pharmaceutical industry. Lower drug development costs, and hence prices, can be brought about by abolishing national … drug administrations and replacing them with private certification boards that compete on the basis of safety, efficiency …
Persistent link: https://www.econbiz.de/10014060120
Before a new drug can be marketed the Food and Drug Administration must be satisfied that it is safe and effective … been advocated. This paper challenges the central argument in the debate on the topic, namely that drug regulation and drug … innovation are necessarily at odds with each other. Although intuitively appealing, the argument that drug regulation negatively …
Persistent link: https://www.econbiz.de/10012754003
of new drug patents using two quasi-experimental approaches: one based on changes in patent laws and another on the … of new drug development, generic entry, and patent length and scope. Optimal policy calls for shorter but broader …
Persistent link: https://www.econbiz.de/10012802183
We investigate women's fertility, labor and marriage market responses to large declines in child and maternal mortality that occurred following a major medical innovation in the US. In response to the decline in child mortality, women delayed childbearing and had fewer children overall. Fewer...
Persistent link: https://www.econbiz.de/10011893607
We investigate women's fertility, labor, and marriage market responses to large declines in child mortality in the U.S. Fertility declined on the intensive margin as expected. However, despite the increasing value of having at least one child, a larger share of women remained childless. We...
Persistent link: https://www.econbiz.de/10011938854
We investigate women's fertility, labor and marriage market responses to large declines in child and maternal mortality that occurred following a major medical innovation in the US. In response to the decline in child mortality, women delayed childbearing and had fewer children overall. Fewer...
Persistent link: https://www.econbiz.de/10012912765
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/10013477204
Background: Rising cancer drug prices pose a challenge for patients and healthcare systems in the US. Whilst prices are … routinely assigned to a drug’s original indication receiving US Food and Drug Administration (FDA) approval, the influence of … drug prices, distinctly analyzing original and supplemental indications.Data and Methods: Clinical trial evidence …
Persistent link: https://www.econbiz.de/10014357763
We investigate whether increased racial diversity of clinical trial principal investigators could increase the enrollment of Black patients, which currently lags population and disease-burden shares. We conducted a survey experiment in which respondents were shown a photo of a current NIH...
Persistent link: https://www.econbiz.de/10014372489