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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 …
Trends In Protection For Informational Works Under Copyright Law During The 19th And 20th Centuries, Miriam Bitton
Trends In Protection For Informational Works Under Copyright Law During The 19th And 20th Centuries, Miriam Bitton
Michigan Telecommunications & Technology Law Review
The debate over databases protection has failed to identify and discuss some of its most basic and preliminary assumptions, accepting instead many of the historical aspects involved as given. This Article therefore seeks to challenge these underlying assumptions by providing a fresh look at the historical dimension of the debate. One common argument regarding database protection is that the U.S. Supreme Court decision in Feist v. Rural Publications Inc. brought about a dramatic change in the legal landscape, displacing the then-accepted "sweat of the brow" rationale for protecting rights in databases. This Article's historical analysis therefore thoroughly examines the treatment …
Taking A Bite Out Of Circumvention: Analyzing 17 U.S.C. 1201 As A Criminal Law, Jason M. Schulz
Taking A Bite Out Of Circumvention: Analyzing 17 U.S.C. 1201 As A Criminal Law, Jason M. Schulz
Michigan Telecommunications & Technology Law Review
...information content providers who depend heavily on copyright law are growing increasingly wary of advances in digital technology that allow manipulation of their content and potentially diminish the effectiveness of their copyright protection. Technology firms, on the other hand, are looking more and more at developing products which provide low-cost, high quality access to content without restriction. Thus, as technologists work feverishly to find new ways to free up information, content providers are fighting just as hard to constrain access in order to prevent market-killing duplication and distribution of their works. These two codependent yet clashing interest groups recently met …