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Headlines Tagged with FDA 9,686 headlines found

5 Views

Philip Morris Products S.A. Modified Risk Tobacco Product (MRTP) Applications: Clarification: No Deadline Set for Public Comments on Philip Morris Products S.A. MRTP Applications

We anticipate making amendments received thus far publicly available over the next several months, and amendments received in the future will be made publicly available as they are redacted....FDA intends to issue another notice in the Federal Register an
FDA - Food and Drug Administration
added Dec 8, 2017 23:37
12 Views

Heat-not-burn cigarettes may still harm the heart, as FDA mulls approval

Tobacco control researcher Stanton Glantz, Ph.D., is publicly urging the FDA to deny Philip Morris’s application. He said a close reading of the company’s FDA application shows no detectable difference between the health effects of IQOS and regular cigar
American Heart Association (AHA)
added Dec 8, 2017 09:11
7 Views

GLANTZ: PMI’s MRTP Application for IQOS Does Not Consider IQOS’s Appeal to Youth or Adolescents

PMI’s MRTP Application for IQOS Does Not Consider IQOS’s Appeal to Youth or Adolescents, or the Likelihood that Youth and Adolescents will Initiate Tobacco Use with IQOS or Use IQOS with Other Tobacco Products
Center for Tobacco Control Research and Education (UCSF)
added Dec 9, 2017 02:50
3 Views

Guidance: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments / An unpublished Notice by the Food and Drug Administration on 12/08/2017

This revised guidance describes the compliance policy for product listing information updates for deemed tobacco products for persons who owned or operated domestic manufacturing establishments engaged in the manufacture of deemed products prior to August
Federal Register
added Dec 7, 2017 19:55
9 Views

Will the FDA’s New Tobacco Strategy Be a Game Changer? [FREE FULL TEXT]

e-Cigarettes might have a role in helping smokers quit, but delaying their regulation won’t help motivate manufacturers to demonstrate that their products are safe and effective as smoking cessation aids, Fiore said.
JAMA - Journal of the American Medical Association
added Dec 8, 2017 17:55
13 Views

FDA seeks new ways to unhook smokers

The agency’s new Nicotine Steering Committee will explore new options for safe and effective smoking cessation. The agency plans to seek public input at a Jan. 26 hearing, the Washington Post reported.
The Business Journals
added Dec 7, 2017 13:35
2 Views

Sunovion Receives FDA Approval for Lonhala™ Magnair™ Inhalation Solution to Treat COPD

approved the New Drug Application (NDA) for Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution (25 mcg twice daily), also known as SUN-101/eFlow®, for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmo
Business Wire
added Dec 6, 2017 17:10
5 Views

DoSomething.org and truth® Partner With Actor Dexter Darden for #MyBigRegret

In 2011, the FDA had an opportunity to ban menthols, but due to a "lack of research," they never did. Despite the FDA's own scientific review concluding that menthol cigarettes pose a public health risk above that seen with non-menthol cigarettes, mentho
PR Newswire
added Dec 5, 2017 17:45
8 Views

FDA Ties E-Cigs to Nicotine Replacement Therapies

While not saying directly that it is considering e-cigarettes be deemed an NRT, officials did say that the review process will involve input from multiple stakeholders, including researchers, people from the medical field, tobacco manufacturers and profe
CSP News (Convenience Store/Petroleum)
added Dec 9, 2017 02:27
19 Views

The Clock is Delayed but Still Ticking for E-Cigarettes

Tucked away in the Fiscal Year 2018 House of Representatives Agriculture, Rural Development, FDA, and Related Agencies Appropriations bill is Section 753, also called the Cole-Bishop provision, which would change the predicate date for newly deemed tobacc
Citizens Against Government Waste (CAGW)
added Dec 8, 2017 09:55
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