Articles with "fda guidance" as a keyword



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Extending FDA guidance to include consumer medication information (CMI) delivery on mobile devices

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Published in 2017 at "Research in Social and Administrative Pharmacy"

DOI: 10.1016/j.sapharm.2016.01.001

Abstract: &NA; This paper describes the current state of consumer‐focused mobile health application use and the current U.S. Food and Drug Administration (FDA) guidance on the distribution of consumer medication information (CMI), and discusses recommendations and… read more here.

Keywords: cmi; medication information; information; fda guidance ... See more keywords
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FDA guidance on cardiovascular risk of antidiabetic therapies: One decade later

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Published in 2019 at "Diabetes"

DOI: 10.1111/dom.13669

Abstract: The 2008 FDA guidance for industry on cardiovascular (CV) risk of new antidiabetic therapies arose from a history of CV safety concerns brought to a head by findings with rosiglitazone and the ACCORD trial of… read more here.

Keywords: antidiabetic therapies; fda guidance; cardiovascular risk;
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Relative increases in direct-to-consumer menthol ads following 2020 FDA guidance on flavoured e-cigarettes

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Published in 2022 at "Tobacco Control"

DOI: 10.1136/tobaccocontrol-2021-057069

Abstract: Objective To examine potential changes in email and direct mail advertisements for flavoured e-cigarettes following the 2020 Food and Drug Administration (FDA) flavour guidance. Methods Digital copies of e-cigarette advertisements were obtained from Mintel Comperemedia… read more here.

Keywords: flavoured cigarettes; menthol; 2020 fda; following 2020 ... See more keywords
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PaxlovidTM Information From FDA and Guidance for AES Members

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Published in 2022 at "Epilepsy Currents"

DOI: 10.1177/15357597221088415

Abstract: This American Epilepsy Society (AES) official statement provides information and preliminary guidance to Society members related to the U.S. Food & Drug Administration (FDA) December 22, 2021 Emergency Use Authorization for Paxlovid™ for the oral… read more here.

Keywords: information; guidance aes; paxlovidtm information; guidance ... See more keywords