...Thomas J. Hwang; Jerry Avorn; Aaron S. Kesselheim Abstract The US Food and Drug Administration (FDA) uses rulemaking as one of its primary tools to protect the public health and implement laws enacted by Congress and the president. Because of the many effects that these rules have on social welfare...

...Mary K. Olson This article examines the effects of the user fee reform on the speed of drug review in the U.S. Food and Drug Administration. The results show that even after controlling for increased agency resources, the reform reduced review times among new-drug approvals by 34 percent (95...

...Karen L. Baird The National Institutes of Health (NIH) and Food and Drug Administration (FDA) have both recently revised their policies regarding the inclusion of women in clinical trials. Pressured by women's health activists and members of Congress, the NIH has vastly improved its policies; it...

... role of the Food and Drug Administration. Copyright © 1978 by the Department of Health Administration, Duke University Press 1978 Laetrile and the FDA: A Case of Reverse Regulation John F. Cannizzaro, and Madelon M Rosenfeld, Capital University Law School Abstract...

... should define and assess safety and effectiveness, and how? In the first section of the paper we describe the types of stem cells that may be therapeutically effective. We then describe how the US Food and Drug Administration asserted regulatory authority over certain stem cell interventions and the...

...Natalie Hemmerich; Elizabeth G. Klein; Micah Berman Abstract Electronic Nicotine Delivery Systems (ENDS) were introduced into the US market in 2007, and until recently these devices were unregulated at the federal level. In 2014, the US Food and Drug Administration (FDA) published a Notice of...

... Outbreak of Obesity. New York Times, June 3 . Nestle, Marion. 2002 . Food Politics . Berkeley, CA: University of California Press. Saul, Stephanie. 2005 . Drug Makers Race to Cash In on Nation's Fight against Fat. New York Times, April 3 . Books...

... further potential solutions to the con- cerns raised within these subthemes. We then put the relationship between the provinces and the federal government into an international context by drawing parallels between the Canadian interactions and those of various parts of the US Food and Drug...

... reliance on the free market in the United States have led to allegations of overpricing and manipulation of the terms and intent of the U.S. Orphan Drug Act.1 More specifically, several 1. U.S. P.L. 97-414, 97th Cong., 1st sess., 4 January 1983, Federal Food, Drug, and Cosmetic Act Amendments...

... and Drug Administration. 2002 . Improving Public Health through Human Drugs: CDER Report to the Nation 2002 . Rockville, MD: U.S. Food and Drug Administration. Available online at www.fda.gov/cder/reports/rtn/2002/Rtn2002.PDF . Hilts, Philip. 2003 . Protecting American's Health: The FDA...

..., Maryland; Dr. Mark Novitch, Associate Commissioner, Food and Drug Administration., Rockville, Maryland; Dr. James Russo, Vice President for Public Relations, Pharmaceutical Manufacturers Association, Washington, DC. Maximum Allowable Cost: Can the Government Control Drug Costs? A Retrospective...

... to dispassionate historical overview. There is a description of the U.S. generic drug industry scan- dal, which occurred in the late 1980s and involved the U.S. Food and Drug Administration, but its significance here is not clear. The chapter on the essential role of government is weak...

... prescriptions abroad may inadvertently get the wrong drugs (US Food and Drug Administration 2006). In 2003 the Spanish Agency for Medi­ cines and Medical Devices warned of confusion between buprenorfine and ibuprofen sold under the same brand in Spain and Ecuador (Council of Europe, Expert Group on Safe...

.... The food industry, alleged by the authors to be fully aware of its role in the obesity epidemic despite oft-repeated public denials, tosses the hot potato of obesity to the diet and drug industries. Currently, health education does not constitute an effective health program—Food Wars and Food...

... (2003) were substantially higher than those of other sources. DiMasi, Hansen, and Grabowski reported an overall average of 5,303 subjects used in tri- als per approved NME, while the Food and Drug Administration (FDA) reported an average of only 2,667 subjects over a much larger sample of...

... grant required that 10 percent of the full allotment be earmarked for alcohol and drug abuse services for women. States were also subject to cost ceilings: From 1982 to 1989, states could use no more than 10 percent of the ADAMH grant for administrative costs, and after 1989 this ceiling decreased...

... contrast with the United States, Canada’s neighbor and principal trading partner, Canada had prohibited direct-­to-­consumer advertising of pharmaceutical products under the federal Food and Drugs Act (R.S., ch. F-­27 [1985 This law states that pharmaceutical companies may not make claims to...

... Contribution Administrators (NAGDCA) . 2006 . 2006 Survey of Plans . Lexington, KY : NAGDCA . Neuman P. Strollo M. K. Gutterman S. Rogers W. H. Li A. Rodday A. M. C. Safran D. G. . 2007 . Medicare Prescription Drug Benefit Progress Report: Findings from a 2006 National...

...Drew Humphries Laura E. Gomez. Misconceiving Mothers: Legislators, Prosecutors, and the Politics of Prenatal Drug Exposure . Philadelphia: Temple University Press, 1997. 256 pp. $59.95 cloth; $19.95 paper. © 2000 by Duke University Press 2000 JHPPL 25.3-05.BkRevs (565-612) 5/12/00 11:59 AM...

... relationship between these terms and the US Food and Drug Administration's (FDA) NDA classifications. Some researchers focus on the development of new molecular entities (NMEs) (or new chemical entities) (DiMasi, Hansen, and Grabowski 2003 ; Sampat and Lichtenberg 2011 ), while others focus on drugs granted...