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Full-Text Articles in Food and Drug Law
Emergent Regulatory Systems And Their Challenges: The Case Of Combination Medical Products, George Horvath
Emergent Regulatory Systems And Their Challenges: The Case Of Combination Medical Products, George Horvath
Washington Law Review
Where regulatory systems overlap, courts and scholars often focus on the undesirable aspects of the overlap—the ways in which systems conflict. One such context involves the regulation of prescription drugs and medical devices by the FDA’s premarket evaluation processes and by state common-law tort and products liability actions. FDA regulation and state common law are often described as separate, conflicting regulatory systems. This Article challenges that description by proposing a model in which FDA premarket evaluation and state common law function as a single regulatory system. This model brings order to the Supreme Court’s seemingly inconsistent medical products preemption cases, …
Greater Uniformity And Centralization: The Regulatory Development Of Chinese Food And Product Safety Under The Wto, Nga Kit (Christy) Tang
Greater Uniformity And Centralization: The Regulatory Development Of Chinese Food And Product Safety Under The Wto, Nga Kit (Christy) Tang
Washington International Law Journal
The WTO Agreements emphasize free trade, which links with diversity, deregulation, and decentralization. China, on the other hand, emphasizes uniformity and centralization, especially regarding the political control and the one-party system of “democratic dictatorship.” China’s joining the WTO, therefore, may be considered as a development that changes the regulatory structure to become more diverse, deregulated, and decentralized. This paper, however, finds the opposite. Under the WTO law, China is encouraged to move towards greater uniformity and centralization with its decentralized and non-uniform settings under the market policy. Moreover, the WTO’s uniform and centralized encouragements can be integrated into the rule-by-man …
The Surprising Reach Of Fda Regulation Of Cannabis Even After Rescheduling, Sean M. O'Connor, Erika Lietzan
The Surprising Reach Of Fda Regulation Of Cannabis Even After Rescheduling, Sean M. O'Connor, Erika Lietzan
Articles
As more states legalize cannabis, the push to “deschedule” it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (FDA) recently approved the first conventional drug containing a cannabinoid derived from cannabis—cannabidiol (CBD) for two rare seizure disorders. This would all seem to bode well for proponents of full federal legalization of medical cannabis. But some traditional providers are wary of drug companies pulling medical cannabis into the regular small molecule drug development system. The FDA’s focus on precise analytical characterization and on individual active and inactive ingredients may be fundamentally inconsistent …