1-20 of 183 Search Results for

fda

Follow your search
Access your saved searches in your account

Would you like to receive an alert when new items match your search?
×Close Modal
Sort by
Journal Article
Journal of Health Politics, Policy and Law (1 June 2004) 29 (3): 397–430.
Published: 01 June 2004
... Control in Federal Regulation. American Political Science Review 90 : 283 -302. ———. 1999 . Bureaucratic Choice as a Stopping Problem: A Theoretical and Empirical Analysis of FDA Drug Review . Paper presented at the 1999 Midwest Political Science Association Meetings, Chicago, April. Dranove, D...
Journal Article
Journal of Health Politics, Policy and Law (1 June 2004) 29 (3): 431–442.
Published: 01 June 2004
..., Agency Waiting Costs, and FDA Drug Approval. American Journal of Political Science 46 : 490 -505. ———. 2003 . Protection without Capture: Product Approval by a Politically Responsive, Learning Regulator . Unpublished manuscript. Harvard University. Carpenter, Daniel P., Michael Chernew, Dean G...
Journal Article
Journal of Health Politics, Policy and Law (1 June 1999) 24 (3): 531–565.
Published: 01 June 1999
...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...
Journal Article
Journal of Health Politics, Policy and Law (1 April 1978) 3 (2): 181–195.
Published: 01 April 1978
... 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...
Image
Published: 01 December 2013
Figure 2 Coverage Restrictions for Eligible Anticancer Drugs, FDA Approved, 2004–2008 Source : Mason et al. 2010 . Reprinted with permission. © 2010 American Society of Clinical Oncology. All rights reserved. Figure 2. Coverage Restrictions for Eligible Anticancer Drugs, FDA Approved, 2004 More
Journal Article
Journal of Health Politics, Policy and Law (1 August 2017) 42 (4): 645–666.
Published: 01 August 2017
...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...
Journal Article
Journal of Health Politics, Policy and Law (1 August 2014) 39 (4): 751–780.
Published: 01 August 2014
...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...
Journal Article
Journal of Health Politics, Policy and Law (1 August 2017) 42 (4): 607–644.
Published: 01 August 2017
...Daniel Carpenter; Gregory N. Connolly; Lauren Kass Lempert Abstract The Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009 creates the first national system of premarket regulation of tobacco products in American history. The FDA must now review and give marketing authorization to...
Image
Published: 01 April 2016
Figure 1 Trends in NDA Approvals for Publicly Traded Firms, 1999–2009 Source : Authors' analyses of data from Drugs@FDA for publicly traded firms. Complete description in “Data” section. Notes : NDAs=new drug applications; NME=new molecular entity Figure 1. Trends in NDA Approvals for More
Image
Published: 01 August 2014
Figure 2 A Timeline of the Rulemaking Process Relating to Restricting Access to Ephedrine Dietary Supplements   Notes : The annotated timeline depicts the history and development of FDA's rule to restrict access to dietary supplements containing ephedrine alkaloids due to an increased risk of More
Image
Published: 01 April 2016
FDA from 1999 to 2009. Notes : R&D=research and development; SG&A=selling, general, and administrative; NDA=new drug application Figure 2. Trends in Average Firm R&D and SG&A Expenditures (in Millions of Dollars), 1999–2009. / Source: Authors' analyses of data from firms' 10-K More
Image
Published: 01 August 2014
Figure 3 A Timeline of the Rulemaking Process relating to Phasing Out of Metered Dose Inhalers Containing Ozone-Depleting Substances (Albuterol)   Notes : The annotated timeline depicts the history and development of FDA's rule to phase out metered-dose inhalers containing albuterol, which was More
Journal Article
Journal of Health Politics, Policy and Law (1 October 2016) 41 (5): 917–937.
Published: 01 October 2016
... of the debate has to do with whether the US Food and Drug Administration (FDA) should regulate as a medical drug some or all stem cell interventions. FDA-regulated drugs cannot be sold as medical products without the agency's prior approval, given only after determining that the drug has an...
Journal Article
Journal of Health Politics, Policy and Law (1 April 2016) 41 (2): 157–179.
Published: 01 April 2016
...Figure 1 Trends in NDA Approvals for Publicly Traded Firms, 1999–2009 Source : Authors' analyses of data from Drugs@FDA for publicly traded firms. Complete description in “Data” section. Notes : NDAs=new drug applications; NME=new molecular entity Figure 1. Trends in NDA Approvals for...
Journal Article
Journal of Health Politics, Policy and Law (1 August 2003) 28 (4): 615–658.
Published: 01 August 2003
... Cycle of a Public Issue . Pittsburgh, PA: University of Pittsburgh Press. Brickman, R., S. Jasanoff, and T. Ilgen. 1985 . Controlling Chemicals: The Politics of Regulation in Europe and the United States . Ithaca, NY: Cornell University Press. Burkholz, H. 1994 . The FDA Follies . New York...
Journal Article
Journal of Health Politics, Policy and Law (1 August 2017) 42 (4): 573–577.
Published: 01 August 2017
... tobacco marketplace. The FDA can clamp down on the tobacco industry's ability to clandestinely modify or introduce new tobacco products and can judge whether the public health is served by market entry of altered tobacco products. Yet the law also continues an alternative pathway for market entry by which...
Journal Article
Journal of Health Politics, Policy and Law (1 June 2004) 29 (3): 553–556.
Published: 01 June 2004
... Policy postdoctoral fellowship in 2000 at the University of Michigan. He received a Robert Wood Johnson Founda- tion Investigator Award for 2004–2006 for this project, entitled “Reputation and Reg- ulation: A Study of Pharmaceutical Policy at the FDA.” His published articles on FDA regulation have...
Journal Article
Journal of Health Politics, Policy and Law (1 June 1986) 11 (3): 501–523.
Published: 01 June 1986
... Medical Device Amend- ments of 1976 was to authorize the Food and Drug Administration (FDA) to ensure medical product safety. * The government also promotes innovation, pri- marily through support for basic and applied research.' Congress expanded public access for millions of elderly citizens...
Journal Article
Journal of Health Politics, Policy and Law (1 August 1995) 20 (4): 973–1000.
Published: 01 August 1995
... presented at the Institute of Medicine Conference on Barriers to Vaccine Innovation. Washington, DC, 28–29 November. FDA Recalls and Court Actions: Vivotif Berna Typhoid Vaccine, Live Oral Ty21a. 1991 . FDC Reports Pink Sheet. Bethesda, MD: Food and Drug Administration. 12 August. Freeman , P...
Journal Article
Journal of Health Politics, Policy and Law (1 June 2004) 29 (3): 443–450.
Published: 01 June 2004
... -127. Olson, M. K. 1997 . Firm Characteristics and the Speed of FDA Approval. Journal of Economics and Management Strategy 6 : 377 -401. ———. 2000 . Regulatory Reform and Bureaucratic Responsiveness to Firms: The Impact of User Fees in the FDA. Journal of Economics and Management Strategy 9...