PMTA is takerdunud in kohtuasjad, FDA lõpuks tunnistab nõu, 18 miljon to ehita a kiire tubakas jälgimine keskus
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PMTA is takerdunud in kohtuasjad, FDA lõpuks tunnistab nõu, 18 miljon to ehita a kiire tubakas jälgimine keskus
Vastavalt to news from the US media on June 1 local time, FDA and NIH jointly announced the establishment of a new CRST (Tobacco Rapid Monitoring Center) with a grant of US$18 million for a period of five years.
Vastav to uudised from the US media on June 1 local time, the FDA (US Food and Drug Administration) and the US National Institutes of Health (NIH) jointly announced the establishment of a new CRST (Rapid Tobacco Monitoring Center) with a grant of US$ 18 million. five years. The function of the Tobacco Rapid Monitoring Center is to to provide more data on the sales and marketing of tobacco products to different institutions, keskendumine on kiire tootmine andmed.
Millal the relevant media reported on this incident, it was selgelt mainitud et the the Tobacco Rapid Monitoring Center was to deal with the rapid popularity of electronic cigarettes (eriti seas young people). Regulatory functions (sigaretid, suitsuvaba tobacco, medical products) in the United States do not have capacity to address issues related to e-sigaretid.
To put it bluntly, the FDA has moved to the rescue - it is really unable to deal with the current massive PMTA applications, and has to introduce more professional monitoring capabilities to help it improve its regulatory capabilities and efficiency for e-cigarettes.
The Tobacco Rapid Surveillance Center is staffed by eight faculty members from Rutgers University, as well as from Roswell Park Cancer Institute, East Carolina University, Stanford University, University of Kentucky, Ohio State University, Columbia University and Westat, Inc. 13 "co-investigators" lead.
In response, Cristine Delnevo, principal investigator of the Tobacco Rapid Monitoring Center and director of the Center for Tobacco Research at Rutgers University, said in a press release: "This has never been attempted before. No one has collected such kõikehõlmav teave, let alone Said to be sorteeritud out and levitatud kiiresti. We believe this will provide FDA with õigeaegselt and väärtuslik data to assist the tobacco tobacco regulatory töö volitatud poolt kongress."
Tubakas kiire jälgimine mitte ainult aitab FDA to make appropriate enforcement, but also help to assess the impact of policies that have not yet been characterized. For example, if the use of mentool in cigarettes is banned, will people who smoke mentool cigarettes quit smoking? Should I switch to to non-mentool sigaretid? Switching to e-sigaretid or nikotid? Our goal is to monitor market and consumer changes in as real aeg as võimalik. "
In fakt, the FDA's move is not difficult to understand. Gewu Consumer tweeted yesterday, "Fight PMTA kohtuasjad iga päev! FDA direktor müüb õnnetult to ask for a "sword of justice", and hiljuti met koos ministeerium of Justice" mainitud et FDA direktor Robert Carley has hiljuti valatud välja mõru vesi. The FDA on olnud võimetu to toimetulek koos praegune olukord ja on nägu rohkem kui 40 kohtuasjad vastu PMTA (nende hulgas enamasti ettevõtetelt see ebaõnnestus to apply).
In the assessment of the Reagan-Udall Foundation in December last year, it was clear stated that the FDA lacks a clear and comprehensive long-term plan for the regulation of e-cigarettes. Diamond takek over the portselan job again.
puudub puudub FDA's võime jälgida ja analüüsida on parim peegeldub sisse läbilaskevõime ja edusammud PMTA.
On September 9, 2020, the FDA nõutav see kõik e-sigaretid et olid käivitatud enne august 8, 2016 peab esitama a PMTA taotlus või taganema from the United States, and promised to complete all reviews on September 9, 2021. As a result, until today, only 7 (There are even a hunch of aegunud antiik tooted in it), and the promised completion approval time has been delayed again and jälle.
