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It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
Michigan Telecommunications & Technology Law Review
Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping …
Economic Espionage Act--Reverse Engineering And The Intellectual Property Public Policy, The, Craig L. Uhrich
Economic Espionage Act--Reverse Engineering And The Intellectual Property Public Policy, The, Craig L. Uhrich
Michigan Telecommunications & Technology Law Review
The publicity surrounding[...] incidents of industrial espionage resulted in a push for federal protections. In response to this pressure from U.S. industries, Congress passed the Economic Espionage Act of 1996 ("EEA"). The EEA protects trade secrets through the use of federal criminal sanctions." The EEA's provisions are introduced in Part I. Trade secrets are a form of intellectual property. Therefore, a basic understanding of intellectual property law is important to an analysis of the EEA. Part II of this Article provides an overview of the various forms of intellectual property. To be effective, the EEA must complement existing intellectual property …
Protection For Trade Secrets Under The Toxic Substances Control Act Of 1976, Paula R. Latovick
Protection For Trade Secrets Under The Toxic Substances Control Act Of 1976, Paula R. Latovick
University of Michigan Journal of Law Reform
This article will examine the protection provided by the Act and the measures the EPA has adopted for implementing the Act's provisions. The approach will be to focus on the different functional areas in which disclosure may take place. Part I examines the scheme for designating information as confidential and the mechanics of the reporting system under TSCA. Part II deals with disclosures of confidential information made while implementing the TSCA. Part III focuses on legal disclosures of information submitted as confidential. Finally, Part IV examines the measures taken within the EPA to guarantee the safety of confidential information, the …