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Avoiding Animal Testing Under the U.S. Family Smoking Prevention and Tobacco Control Act

Avoiding Animal Testing Under the U.S. Family Smoking Prevention and Tobacco Control Act APPLIED IN VITRO TOXICOLOGY COMMENTARY Volume 3, Number 1, 2017 Mary Ann Liebert, Inc. DOI: 10.1089/aivt.2016.0033 Avoiding Animal Testing Under the U.S. Family Smoking Prevention and Tobacco Control Act Joseph R. Manuppello ext-generation nicotine products, including elec- guidance on modified risk tobacco product ( MRTP) applica- N tronic nicotine delivery systems (ENDS), are the focus tions. As a result, concern remains that manufacturers of of the U.S. Food and Drug Administration’s (FDA’s) conten- next-generation nicotine products will conduct animal tests tious May 2016 rule deeming tobacco products to be subject in support of marketing applications. to the Family Smoking Prevention and Tobacco Control Act More recently, in its deeming rule and guidance docu- (FSPTCA) as well as of its accompanying draft guidance for ments on tobacco product master files (TPMFs) and premar- industry on premarket applications for ENDS. This timely ket applications for ENDS, FDA has offered several means special issue of Applied In Vitro Toxicology addresses the ur- by which the number of tests conducted might be reduced. gent need for in vitro tests and nonanimal testing strategies to In its deeming rule, FDA states its intention to issue stan- evaluate the toxicity and abuse liability of next-generation http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Applied In Vitro Toxicology Mary Ann Liebert

Avoiding Animal Testing Under the U.S. Family Smoking Prevention and Tobacco Control Act

Applied In Vitro Toxicology , Volume 3 (1): 2 – Mar 1, 2017

Avoiding Animal Testing Under the U.S. Family Smoking Prevention and Tobacco Control Act

Applied In Vitro Toxicology , Volume 3 (1): 2 – Mar 1, 2017

Abstract

APPLIED IN VITRO TOXICOLOGY COMMENTARY Volume 3, Number 1, 2017 Mary Ann Liebert, Inc. DOI: 10.1089/aivt.2016.0033 Avoiding Animal Testing Under the U.S. Family Smoking Prevention and Tobacco Control Act Joseph R. Manuppello ext-generation nicotine products, including elec- guidance on modified risk tobacco product ( MRTP) applica- N tronic nicotine delivery systems (ENDS), are the focus tions. As a result, concern remains that manufacturers of of the U.S. Food and Drug Administration’s (FDA’s) conten- next-generation nicotine products will conduct animal tests tious May 2016 rule deeming tobacco products to be subject in support of marketing applications. to the Family Smoking Prevention and Tobacco Control Act More recently, in its deeming rule and guidance docu- (FSPTCA) as well as of its accompanying draft guidance for ments on tobacco product master files (TPMFs) and premar- industry on premarket applications for ENDS. This timely ket applications for ENDS, FDA has offered several means special issue of Applied In Vitro Toxicology addresses the ur- by which the number of tests conducted might be reduced. gent need for in vitro tests and nonanimal testing strategies to In its deeming rule, FDA states its intention to issue stan- evaluate the toxicity and abuse liability of next-generation

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Publisher
Mary Ann Liebert
Copyright
© Joseph R. Manuppello, 2017; Published by Mary Ann Liebert, Inc.
ISSN
2332-1512
eISSN
2332-1539
DOI
10.1089/aivt.2016.0033
Publisher site
See Article on Publisher Site

Abstract

APPLIED IN VITRO TOXICOLOGY COMMENTARY Volume 3, Number 1, 2017 Mary Ann Liebert, Inc. DOI: 10.1089/aivt.2016.0033 Avoiding Animal Testing Under the U.S. Family Smoking Prevention and Tobacco Control Act Joseph R. Manuppello ext-generation nicotine products, including elec- guidance on modified risk tobacco product ( MRTP) applica- N tronic nicotine delivery systems (ENDS), are the focus tions. As a result, concern remains that manufacturers of of the U.S. Food and Drug Administration’s (FDA’s) conten- next-generation nicotine products will conduct animal tests tious May 2016 rule deeming tobacco products to be subject in support of marketing applications. to the Family Smoking Prevention and Tobacco Control Act More recently, in its deeming rule and guidance docu- (FSPTCA) as well as of its accompanying draft guidance for ments on tobacco product master files (TPMFs) and premar- industry on premarket applications for ENDS. This timely ket applications for ENDS, FDA has offered several means special issue of Applied In Vitro Toxicology addresses the ur- by which the number of tests conducted might be reduced. gent need for in vitro tests and nonanimal testing strategies to In its deeming rule, FDA states its intention to issue stan- evaluate the toxicity and abuse liability of next-generation

Journal

Applied In Vitro ToxicologyMary Ann Liebert

Published: Mar 1, 2017

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