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Journal Article
J Health Polit Policy Law (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...
Journal Article
J Health Polit Policy Law (2022) 47 (6): 649–672.
Published: 01 December 2022
... and Drug Administration (FDA) has flexibility in how it applies this standard. Methods: The authors conducted a systematic literature review of studies evaluating the design and outcomes of the key trials supporting new drug approvals in the United States. They extracted data on the trial characteristics...
FIGURES
Includes: Supplementary data
Journal Article
J Health Polit Policy Law (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 Unpublished manuscript.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...
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in Twenty Years of Using Economic Evaluations for Drug Reimbursement Decisions: What Has Been Achieved?
> Journal of Health Politics, Policy and Law
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.
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Journal Article
J Health Polit Policy Law 11670184.
Published: 15 November 2024
... from late August to early October 2020. We identify several plausible triggers for this spike, all pertaining to the FDA and electoral politics. Heightened vaccine hesitancy occurred among Democrats, Asian and Black citizens, as well as college-educated respondents. Turbulence mainly affected those who...
Includes: Supplementary data
Journal Article
J Health Polit Policy Law (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...
Journal Article
J Health Polit Policy Law (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
J Health Polit Policy Law (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...
Journal Article
J Health Polit Policy Law (2023) 48 (5): 799–820.
Published: 01 October 2023
...Neeraj G. Patel; Aaron S. Kesselheim; Jonathan J. Darrow Abstract Since 2004, the US Food and Drug Administration (FDA) has had the authority to allow access to unapproved medical products via the Emergency Use Authorization (EUA) pathway during times of emergency. It was rarely used until...
Journal Article
J Health Polit Policy Law (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...
FIGURES
Journal Article
J Health Polit Policy Law (2023) 48 (4): 485–510.
Published: 01 August 2023
..., and the multiple strategies advocates have pursued to challenge these restrictions, including lobbying the FDA to remove the restrictions, obtaining a limited research exemption from FDA restrictions, and suing the FDA during the COVID-19 pandemic. The article pays particular attention to the influence of research...
FIGURES
Journal Article
J Health Polit Policy Law (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...
FIGURES
Journal Article
J Health Polit Policy Law (2021) 46 (3): 487–504.
Published: 01 June 2021
...Sheng Liu; Michelle M. Mello; Aaron S. Kesselheim Abstract Context: Food and Drug Administration (FDA) rules restrict pharmaceutical manufacturers from promoting drugs for non-FDA-approved (off-label) indications. When manufacturers violate this rule, it has in many cases led to unsafe prescribing...
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Includes: Supplementary data
Journal Article
J Health Polit Policy Law (2022) 47 (6): 673–690.
Published: 01 December 2022
...Rachel E. Sachs; Shelley A. Jazowski; Kyle A. Gavulic; Julie M. Donohue; Stacie B. Dusetzina Abstract Many state Medicaid officials are concerned about rising prescription drug spending, particularly drugs approved through the Food and Drug Administration's (FDA) accelerated approval pathway...
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Includes: Supplementary data
Journal Article
J Health Polit Policy Law (2016) 41 (5): 917–937.
Published: 01 October 2016
... were sent back to Dr. Jones, who later injected them into Perry's spine and bloodstream while conducting the back surgery (Berfield 2013 ). Establishing the FDA's regulatory authority over some stem cell interventions does not resolve issues about the type and amount of evidence regarding...
Journal Article
J Health Polit Policy Law (2003) 28 (4): 615–658.
Published: 01 August 2003
... . 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: Basic. Burstall, M. L. 1991...
Journal Article
J Health Polit Policy Law (2016) 41 (2): 157–179.
Published: 01 April 2016
... too are invoked without a clear sense of the 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...
FIGURES
Journal Article
J Health Polit Policy Law (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
J Health Polit Policy Law (1986) 11 (3): 501–523.
Published: 01 June 1986
... the 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
J Health Polit Policy Law (2024) 49 (1): 73–98.
Published: 01 February 2024
... © 2024 by Duke University Press 2024 pharmaceutical regulation vaccines political economy COVID-19 FDA Policy responses to the COVID-19 pandemic present unique opportunities to understand key features of health politics and policy, and their study can help improve policy making during...
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