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Coming soon: deadline for product registration in the US

15th September 2017 | Regulatory briefing |

North America
United States
Public Health and Medicine
Regulation and Legislation
Regulatory briefing

The deadline for the US Food and Drug Administration (FDA) product registrations for manufacturers is swiftly approaching. From 30th September, manufacturers need to register with the FDA and submit product lists, including labelling and advertisements, to the agency. This deadline was initially December 2016, but the FDA extended it for the industry. The deadlines differ for small and large-scale companies.

From Russian elevators to US taxes, a change is gonna come

3rd August 2017 | Regulatory briefing |

California
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Europe
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Kansas
North America
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Regulation and Legislation
Regulatory briefing

2017 has already been a significant year in the short history of e-cigarettes – and there is more to come in the remaining five months of a the year

U.S. Capitol, Washington

In Congress, deeming reformers welcome FDA’s policy shift

31st July 2017 | Regulatory briefing |

North America
United States
Policy and Politics
Regulatory briefing

The bipartisan duo attempting to modify the FDA’s deeming regulations in the US Congress reacted with cautious optimism to commissioner Scott Gottlieb’s sweeping new policy plan, which many see as a nod for safer alternatives to traditional tobacco products.

FDA headquarters, Maryland

FDA extends PMTA deadline by nearly four years

28th July 2017 | Regulatory briefing |

North America
United States
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory briefing

The US Food and Drug Administration has taken a major step toward easing the demands of the deeming regulations, giving e-cig manufacturers nearly an extra four years to submit their PMTAs.

No relief from deeming regs as US Senate approves key spending bill

21st July 2017 | Regulatory briefing |

North America
United States
Washington
Washington D.C.
Policy and Politics
Regulation and Legislation
Regulatory briefing

The industry’s hopes that a US federal spending bill would reduce the impact of the Food and Drug Administration’s (FDA’s) deeming regulations were disappointed this week when a Senate committee approved a version that makes no reference to tobacco products.

Passed unanimously by the Senate Appropriations Committee, the measure remained silent not only on e-cigarettes but on tobacco products in general.

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