This report tracks and analyses the challenges brought to court by vape companies of their marketing denial orders (MDOs) of their premarket tobacco product applications (PMTAs) ...
This report examines the challenge brought to court by Triton and Vapetasia, against the MDOs issued by the US FDA in response to both companies’ premarket tobacco product applications (PMTAs)...
China-based Shenzhen IVPS Technology, parent to the Smok vaping device brand, has appealed the US FDA's marketing denial order (MDO) for six Smok-branded e-cigarette kits and parts ...
A federal court has ordered the US Food and Drug Administration (FDA) to reconsider its marketing denial order (MDO) for flavoured e-liquids produced by e-cigarette companies Triton and Vapetasia ...
Court reverses two MDOs issued to vape manufacturers ...
This report analyses an apparently change in the FDA's review process for PMTAs, and discusses a number of individual cases where companies have raised it following the issuing of an...
Disagreement among the judges who denied an appeal against a marketing denial order (MDO) issued by the US Food and Drug Administration (FDA) against Triton vaping products has allowed the...
In a big win for the vaping industry, a federal appellate court has ordered the US Food and Drug Administration (FDA) to reconsider its denial of premarket tobacco product applications...
A potentially key but temporary legal win for a vaping company challenging the US Food and Drug Administration (FDA)’s PMTA review process has been transformed into a resounding loss ...
US Food and Drug Administration (FDA) commissioner Robert Califf has authorised an external review of the Center for Tobacco Products (CTP), citing a “series of challenges that have...stressed the agency’s...
Arguments in a US appeal court could demonstrate how judges are likely to perceive arguments from vaping companies contesting US Food and Drug Administration (FDA) decisions on pre-market tobacco applications...
Flavoured e-liquid makers denied a review of marketing denial ...
Juul Labs has been granted a temporary administrative stay while it asks a federal appeal court to halt the Food and Drug Administration (FDA)’s order requiring the removal of all...
E-liquid provider Triton Distribution may have made some progress in its attempt to convince a court that the US FDA was “arbitrary and capricious” in denying its flavoured vaping products...
Written by David Palacios Rubio | 26th November 2021
Breeze Smoke is asking the US Supreme Court to stay a Food and Drug Administration (FDA) marketing denial order (MDO) after the Court of Appeals rejected such motion ...
A US court has granted another stay request to a company that sued the US Food and Drug Administration (FDA) after the agency issued a marketing denial order (MDO) for...
Written by David Palacios Rubio | 29th October 2021
The US Court of Appeals for the Fifth Circuit concluded that the FDA “inadequately addressed or explained” a PMTA that resulted in a MDO, and decided to temporary allow a...
The national authority responsible for drugs regulation in Italy. It is a public body operating autonomously, transparently and according to cost-effectiveness criteria, under the direction of the Ministry of Health...