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Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Michigan Telecommunications & Technology Law Review
Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …
Tiny Things With A Huge Impact: The International Regulation Of Nanomaterials, Dario Picecchi
Tiny Things With A Huge Impact: The International Regulation Of Nanomaterials, Dario Picecchi
Michigan Journal of Environmental & Administrative Law
Mounting evidence demonstrates that nanotechnology and nanomaterials impose severe environmental risks. To minimize these risks, the usage and handling of certain nanomaterials could be addressed under existing treaties such as the Rotterdam Convention, the Stockholm Convention, and the Basel Convention. However, even if existing treaties govern the handling of certain nanomaterials, no treaty effectively regulates all the specific challenges that nanomaterials pose to the global environment. Consequently, a completely new regulatory instrument is required. An international organization could take responsibility for developing and promoting such a nanospecific international legal framework. By incorporating the precautionary principle, a technology transfer, research cooperation, …
The Commodification Of Cryptocurrency, Neil Tiwari
The Commodification Of Cryptocurrency, Neil Tiwari
Michigan Law Review
Cryptocurrencies are digital tokens built on blockchain technology. This allows for a product that is fully decentralized, with no need for a third-party intermediary like a government or financial institution. Cryptocurrency creators use initial coin offerings (ICOs) to raise capital to build their tokens. Cryptocurrency ICOs are problematic because they do not fit neatly within either of two traditional categories—securities or commodities. Each of these categories has their own regulatory agency: the SEC for securities and the CFTC for commodities. At first blush, ICOs seem to be a sale of securities subject to regulation by the SEC, but this is …