US Food & Drug Administration (FDA) Begins Scientific Review of Philip Morris International’s Modified Risk Tobacco Product...
May 25 2017 - 9:51AM
Business Wire
On May 24, 2017, the US FDA published the executive summary and
research summaries supporting Philip Morris International Inc.’s
(PMI) (NYSE/Euronext Paris: PM) Modified Risk Tobacco Product
(MRTP) application for the company’s EHTP. In doing so, the agency
announced that it will publish a notice in the Federal Register
establishing a formal docket for public comments on PMI’s
application at a later date.
PMI submitted the application to the FDA on December 5,
2016.
Publication of PMI’s summaries initiates a substantive
scientific review process by the FDA’s Center for Tobacco
Products.
The FDA has made PMI’s application summaries publicly available
here. The agency will publish additional modules of PMI’s MRTP
application on a rolling basis. The FDA has established a one-year
timetable for reviewing MRTP applications. However, that timing is
non-binding.
“We welcome FDA and public review of the comprehensive
scientific evidence package that we submitted to the agency through
its MRTP application process,” said Dr. Moira Gilchrist, PMI Vice
President Corporate Affairs of Reduced-Risk Products. “PMI’s
application demonstrates our commitment to develop innovative,
smoke-free technologies that can ultimately replace combustible
cigarettes to the benefit of smokers, public health and society at
large.”
Interested members of the scientific and public health
communities can find more information on PMI’s EHTP at:
PMIScienceUSA.com.
About Philip Morris International Inc. (“PMI”)
PMI is the world’s leading international tobacco company, with
six of the world's top 15 international brands and products sold in
more than 180 markets. In addition to the manufacture and sale of
cigarettes, including Marlboro, the number one global
cigarette brand, and other tobacco products, PMI is engaged in the
development and commercialization of reduced-risk products
(“RRPs”). RRPs is the term PMI uses to refer to products that
present, are likely to present, or have the potential to present
less risk of harm to smokers who switch to these products versus
continued smoking. Through multidisciplinary capabilities in
product development, state-of-the-art facilities, and
industry-leading scientific substantiation, PMI aims to provide an
RRP portfolio that meets a broad spectrum of adult smoker
preferences and rigorous regulatory requirements. For more
information,
see www.pmi.com and www.pmiscience.com.
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