To obtain approval to market a drug, a manufacturer must disclose significant amounts of research data to the government agency that oversees the approval process. The data often include information that could help advance scientific progress, and are therefore of great value. But current laws in both the United States and Europe give secrecy great weight. This Article proposes an obligatory sealed-bid auction of the sensitive information based on the experience with similar auctions in mergers and acquisitions, to balance manufacturers\u27 interest in secrecy and the public interest in disclosure
Under present federal regulation, a pharmaceutical company that is attempting to gain Food and Drug ...
The Chapter outlines the relevant provisions governing access to information concerning quality, saf...
abstract: Biosimilar pharmaceuticals are new lower-cost drugs awaiting large-scale approval within t...
To obtain approval to market a drug, a manufacturer must disclose significant amounts of research da...
Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of...
Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhi...
As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to...
Federal regulatory agencies in the United States hold a treasure trove of valuable information essen...
This article addresses the problem of restricted access to industry-sponsored clinical trial data. I...
Context: Changing evidentiary standards and partial shift of the investigational phase of drug appro...
The government, particularly the Food and Drug Administration ( FDA ), heavily regulates the life sc...
Pharmaceutical companies often replace prescription drugs that are already on the market with modifi...
Scandals of selective reporting of clinical trial results by pharmaceutical firms have underlined th...
Lassman examines the tension between transparency and other public health interests in the context o...
Recent allegations that essential safety and efficacy information is often suppressed by medical pro...
Under present federal regulation, a pharmaceutical company that is attempting to gain Food and Drug ...
The Chapter outlines the relevant provisions governing access to information concerning quality, saf...
abstract: Biosimilar pharmaceuticals are new lower-cost drugs awaiting large-scale approval within t...
To obtain approval to market a drug, a manufacturer must disclose significant amounts of research da...
Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of...
Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhi...
As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to...
Federal regulatory agencies in the United States hold a treasure trove of valuable information essen...
This article addresses the problem of restricted access to industry-sponsored clinical trial data. I...
Context: Changing evidentiary standards and partial shift of the investigational phase of drug appro...
The government, particularly the Food and Drug Administration ( FDA ), heavily regulates the life sc...
Pharmaceutical companies often replace prescription drugs that are already on the market with modifi...
Scandals of selective reporting of clinical trial results by pharmaceutical firms have underlined th...
Lassman examines the tension between transparency and other public health interests in the context o...
Recent allegations that essential safety and efficacy information is often suppressed by medical pro...
Under present federal regulation, a pharmaceutical company that is attempting to gain Food and Drug ...
The Chapter outlines the relevant provisions governing access to information concerning quality, saf...
abstract: Biosimilar pharmaceuticals are new lower-cost drugs awaiting large-scale approval within t...