RULEMAKING WITHOUT RULES: AN EMPIRICAL STUDY OF DIRECT FINAL RULEMAKING
- Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations. Kux, Leslie // Federal Register (National Archives & Records Service, Office of;3/23/2012, Vol. 77 Issue 57, p16971
The article offers information on a proposed rule issued by the U.S. Food and Drug Administration Agency to declare the adopted amendments in the regulations of corporative work sharing agreements and memoranda of understanding with the government agencies. The amendments are in accordance with...
- THE JUSTICIABILITY OF FAIR BALANCE UNDER THE FEDERAL ADVISORY COMMITTEE ACT: TOWARD A DELIBERATIVE PROCESS APPROACH. Walters, Daniel E. // Michigan Law Review;Feb2012, Vol. 110 Issue 4, p677
The Federal Advisory Committee Act's requirement that advisory committees be "fairly balanced in terms of the points of view represented and the functions to be performed" is generally considered either nonjusticiable under the Administrative Procedure Act or justiciable but subject to highly...
- Administrative Constitutionalism. Metzger, Gillian E. // Texas Law Review;Jun2013, Vol. 91 Issue 7, p1897
The article discusses administrative constitutionalism in America as of June 2013, focusing on various interpretations of the U.S. Constitution by federal agencies such as the U.S. Food and Drug Administration (FDA), as well as the nation's Departments of Education and Justice (DOJ). The U.S....
- As I See It. Dickinson, James G. // Medical Marketing & Media;Aug2012, Vol. 47 Issue 8, p26
The article discusses the gatekeeping role of the U.S. Food and Drug Administration (FDA), which focuses on helping product innovators.
- FDA. // Taber's Cyclopedic Medical Dictionary (2009);2009, Issue 21, p853
An encyclopedia entry for F.D. which stands for the U.S. Food and Drug Administration (FDA) is presented.
- Restructuring Continues at the FDA. // BioWorld Today;9/20/2011, Vol. 22 Issue 182, p3
The article reports on the restructuring by the U.S. Food and Drug Administration (FDA) of its Office of Medical Policy (OMP).
- DDMAC gets new name, more authority. M. A. // Medical Marketing & Media;Oct2011, Vol. 46 Issue 10, p9
The article reports that the U.S. Food and Drug Administration (FDA) has reorganized its Office of Medical Policy Division of Drug Marketing, Advertising and Communication (DDMAC), wherein it becomes the Office of Prescription Drug Promotion (OPDP) and gets more resources and authority for...
- Determination of Regulatory Review Period for Purposes of Patent Extension; Progel Pleural Air Leak Sealant. Axelrad, Jane A. // Federal Register (National Archives & Records Service, Office of;6/11/2012, Vol. 77 Issue 112, p34389
The article presents information on a notice issued by the U.S. Food and Drug Administration of the U.S. Department of Health and Human Services regarding the extension of an administrative review related patents in the U.S. The notice has been issued in accordance with the U.S. Drug Price...
- Fee for Using a Priority Review Voucher in Fiscal Year 2013. Kux, Leslie // Federal Register (National Archives & Records Service, Office of;9/13/2012, Vol. 77 Issue 178, p56649
The article reports on a notice issued by the U.S. Food and Drug Administration (FDA) regarding fee for priority review voucher in the fiscal year 2013. It informs that the vouchers will be awarded to the sponsors of certain tropical disease product applications after approval of FDA. The...