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Premarket Review

The examination of data and information in an application for premarket review described in sections 505, 510(k), 513(f), 515, or 520(g) or 520(l) of… 
National Institutes of Health

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
Review
2020
Review
2020
Flavoured pod attachments score big as FDA fails to enforce premarket review
On 2 January 2020, the US Food and Drug Administration (FDA) released a final guidance for the tobacco industry that restricted… 
Review
2016
Review
2016
FDA's misplaced priorities: premarket review under the Family Smoking Prevention and Tobacco Control Act
Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant… 
Review
2016
Review
2016
Paternalism, Self-Governance, and Public Health: The Case of E-Cigarettes
This article develops a normative framework for assessing public health laws, using the regulation of e-cigarettes as a case… 
Review
2016
Review
2016
Towards more effective FDA premarket review of new tobacco products
Until the enactment of the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act or TCA), the tobacco… 
Review
2015
Review
2015
Update on indoor tanning legislation in the United States.
Review
2015
Review
2015
The FDA and genetic testing.
This letter provides a response by the Food and Drug Administration to the Special Report, in this issue of the Journal… 
Review
2015
Review
2015
One Size Does Not Fit All: The Public Health Ramifications of Proposed Food and Drug Administration Premarket Review for Extragenital Gonorrhea and Chlamydia Testing.
In October 2014, the US Food and Drug Administration (FDA) announced a proposed new framework to extend their regulatory… 
Review
2010
Review
2010
Regulatory use of computational toxicology tools and databases at the United States Food and Drug Administration's Office of Food Additive Safety
Over 10 years ago, the Office of Food Additive Safety (OFAS) in the FDA's Center for Food Safety and Applied Nutrition… 
Review
1999
Review
1999
The role of Food and Drug Administration regulation of in vitro diagnostic devices--applications to genetics testing.
The Food and Drug Administration (FDA) has been involved in the regulation of in vitro diagnostic devices (IVDs or laboratory… 
Review
1998
Review
1998
Update on FDA regulation of in vitro diagnostic devices.
THE FOOD AND Drug Administration’s (FDA’s) authority for regulation of laboratory tests (in vitro diagnostic devices or IVDs) was… 
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