Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 3 of 3
Full-Text Articles in Law
Preambles As Guidance, Kevin M. Stack
Preambles As Guidance, Kevin M. Stack
Vanderbilt Law School Faculty Publications
Debates over administrative agencies’ reliance on guidance documents have largely neglected the most authoritative source of guidance about the meaning of agency regulations: their preambles. This Article examines and defends the guidance function of preambles. Preambles were designed not only to provide the agency’s official justification for the regulations they introduce, but also to offer guidance about the regulation’s meaning and application. Today, preambles include extensive guidance ranging from interpretive commentary to application examples. Based on the place of preamble guidance as part of the agency’s formal explanation of the regulation and the rigorous internal agency vetting which accompanies that …
18th Annual Open Government Summit: Access To Public Records Act & Open Meetings Act, 2016, Department Of Attorney General, State Of Rhode Island
18th Annual Open Government Summit: Access To Public Records Act & Open Meetings Act, 2016, Department Of Attorney General, State Of Rhode Island
School of Law Conferences, Lectures & Events
No abstract provided.
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai
Articles
As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …