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FDA Briefing Document / January 24-25, 2018 / Meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) (PDF)

It must be emphasized that this document does not represent final findings, recommendations, or conclusions, and that no regulatory decision on the status of these applications has been made. Indeed, an important aspect of our thinking on these applica
FDA - Food and Drug Administration
added Jan 22, 2018 23:07
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Every Try Counts Campaign

FDA’s newest public education campaign, “Every Try Counts” is aimed at encouraging cigarette smokers to quit through messages of support that underscore the health benefits of quitting. These messages will be displayed in and around gas stations or conve
FDA - Food and Drug Administration
added Dec 30, 2017 20:48
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SHAREHOLDER ALERT: Bronstein, Gewirtz & Grossman, LLC Announces Investigation of Philip Morris International Inc. (PM)

Reuters reported that "[f]ormer employees and contractors [of Phillip Morris] have detailed irregularities in the clinical experiments that underpin Philip Morris International's application to the FDA for approval of its iQOS smoking device." The article
PR Newswire
added Dec 22, 2017 16:45
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Spotlight on Science: Tobacco Regulatory Science Fellowship

Are you interested in helping to shape the future of tobacco regulation, or do you know someone who is? Have you considered a fellowship? The tobacco regulatory science fellowship program is a collaboration between CTP and the National Academy of Medici
FDA - Food and Drug Administration
added Dec 22, 2017 15:12
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Letter to FDA protesting the way that they are handling public comment in RJR snus MRTP

Dear Mr. Zeller: Today, December 18, 2017, FDA filed for substantive scientific review six modified risk tobacco product applications (MRTPA) from R.J. Reynolds for six styles of Camel Snus smokeless tobacco products referenced above. We are writing t
Center for Tobacco Control Research and Education (UCSF)
added Dec 22, 2017 02:43
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Public comment submitting Reuters story on PMI irregulatities in IQOS clinical studies to PMI MRTP docket

Lauren Lempert submitted this comment to FDA on December 20...Reuters published a special report on December 20, 2017 identifying several irregularities in Philip Morris' IQOS research. The kind of industry behavior documented in this report is questionab
Center for Tobacco Control Research and Education (UCSF)
added Dec 22, 2017 02:40
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Letter to FDA TPSAC urging them to delay action on IQOS until the record is closed and they can consider public comments

As someone who has served and does serve on committees similar to TPSAC, I do not see how the schedule that the FDA has established for TPSAC’s consideration of this application can permit a responsible assessment of the applications and associated publi
Center for Tobacco Control Research and Education (UCSF)
added Dec 22, 2017 02:39
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GLANTZ: More evidence that NRT without counseling does not work

This is, of course, something that the tobacco industry has known for a long time, ever since shortly after NRT was introduced.... It also points to the folly of the FDA adopting the tobacco industry’s “harm reduction” approach of simply seeking alternati
Center for Tobacco Control Research and Education (UCSF)
added Dec 22, 2017 02:32
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The Philip Morris Files / The secrets of the world’s biggest tobacco company

Part 1: Treaty Blitz... is using its vast resources against efforts to reduce smoking... Part 2: Marlboro Country...marketing cigarettes in India... Part 3: Clinical Complications....FDA for its iQOS...Part 4: Humming Along....lobbying health officials a
Reuters
added Dec 21, 2017 16:05
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The Philip Morris Files PART 3: Clinical Complications: Scientists describe problems in Philip Morris e-cigarette experiments

With a decision expected next year, former employees and contractors have described to Reuters a number of irregularities involving clinical trials that underpin the tobacco giant’s application to the agency. By heating tobacco instead of burning it, the
Reuters
added Dec 21, 2017 16:25
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