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US Food and Drug Administration
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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 (2022) 47 (6): 649–672.
Published: 01 December 2022
... 2018 Infectious diseases 11 X X Totals 30 23 30 Note: COPD = chronic obstructive pulmonary disease. * Total number of approved indications reviewed = 295. ** European Medicines Agency (N = 44) and US Food and Drug Administration...
FIGURES
Includes: Supplementary data
Journal Article
J Health Polit Policy Law (2021) 46 (3): 487–504.
Published: 01 June 2021
... to promote drugs for unapproved uses despite the substantial public health risks. Copyright © 2021 by Duke University Press 2021 prescription drug marketing commercial speech prescription drugs After the Food and Drug Administration (FDA) approves a drug for a particular indication and patient...
FIGURES
Includes: Supplementary data
Journal Article
J Health Polit Policy Law (2022) 47 (6): 673–690.
Published: 01 December 2022
... Program, state Medicaid programs that choose to cover prescription drugs (as all have chosen to do) must cover essentially all Food and Drug Administration (FDA)-approved drugs, with limited statutory carve-outs for cosmetic products, drugs used to “promote fertility,” and erectile dysfunction drugs (42...
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Includes: Supplementary data
Journal Article
J Health Polit Policy Law (2016) 41 (5): 917–937.
Published: 01 October 2016
... 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...
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 (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 (4): 485–510.
Published: 01 August 2023
...Carrie N. Baker Abstract This article examines the decades-long campaign to increase access to abortion pills in the United States, including advocates' work to win US Food and Drug Administration approval of mifepristone and misoprostol for abortion, the continuing restrictions on mifepristone...
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Journal Article
J Health Polit Policy Law (2017) 42 (4): 607–644.
Published: 01 August 2017
... Majid . 2009 . “ The Preventable Causes of Death in the United States: Comparative Risk Assessment of Dietary, Lifestyle, and Metabolic Risk Factors .” PLoS Medicine 6 : 4 . FDA (US Food and Drug Administration) . 1995 . “ Regulations Restricting the Sale and Distribution of Cigarettes...
FIGURES
Journal Article
J Health Polit Policy Law (2004) 29 (3): 431–442.
Published: 01 June 2004
.... Food 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...
Journal Article
J Health Polit Policy Law (1979) 4 (2): 155–175.
Published: 01 April 1979
..., Bethesda, 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...
Journal Article
J Health Polit Policy Law (1978) 3 (2): 181–195.
Published: 01 April 1978
... cited as the Act) indicates that even a food
supplement may be considered a drug if its intended use is the diagnosis,
cure, mitigation, treatment or prevention of disease in man or animal. l6
Therefore, measured against this standard and in view of the product’s
therapeutic claims...
Journal Article
J Health Polit Policy Law (2003) 28 (4): 615–658.
Published: 01 August 2003
... . London: Government of the United Kingdom. Available on-line at www.doh.gov.uk/pprs.htm . Phillips, P. J. 1997 . Regulatory Approval Process. ASAIO Journal 43 (6): 881 -882. Quirk, P. 1980 . Food and Drug Administration. In The Politics of Regulation , ed. J. Q. Wilson. New York: Basic...
Journal Article
J Health Polit Policy Law (2013) 38 (3): 505–544.
Published: 01 June 2013
... – 47 . Strasburger Victor C. 2004 . “Children, Adolescents, and the Media.” Current Problems in Pediatric and Adolescent Health Care 34 , no. 2 : 54 – 113 . US Food and Drug Administration . 2005 . “FDA Updates Labeling for Viagra, Cialis, and Levitra for Rare Post...
Journal Article
J Health Polit Policy Law (2021) 46 (6): 1053–1068.
Published: 01 December 2021
... manufacturers likely have the ability to use their contracts with various supply chain actors to prevent large-scale importation. The Trump administration expected a response from these stakeholders. At the time the NPRM was released, the Food and Drug Administration (FDA) ( 2019 ) released a preliminary...
Journal Article
J Health Polit Policy Law (2016) 41 (2): 157–179.
Published: 01 April 2016
... 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 FDA...
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Journal Article
J Health Polit Policy Law (2004) 29 (3): 397–430.
Published: 01 June 2004
...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...
Journal Article
J Health Polit Policy Law (2003) 28 (2-3): 473–508.
Published: 01 June 2003
... traits,” which benefit the consumer rather than the
farmer, and these include foods that produce drugs in people who eat
them. As a conference announcement sponsored by the Pew Initiative on
1. For this investigation, one of us (Pablo Arredondo) carried out a set of confidential inter-
views...
Journal Article
J Health Polit Policy Law (2010) 35 (6): 1057–1062.
Published: 01 December 2010
... of objective scientific
analysis into their policy making in order to create lists of preferred drugs
(PDLs) for their Medicaid and Children’s Health Insurance Programs
(CHIPs). These PDLs have resulted in more efficient, equally good patient
care while “reducing or even containing the growth of state...
Journal Article
J Health Polit Policy Law (2005) 30 (5): 965–978.
Published: 01 October 2005
... the Reagan and (fi rst) Bush administrations, Bennett held the post
during a critical period in which crack, AIDS, and public anxiety over teen
marijuana use combined to create political opportunities for more conser-
vative approaches to American drug policy. Bennett’s introduction to the
fi rst...
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