"This route was put in correctly," said Mr. Foschi, who is chairman of Costa Crociere S.p.A. "The fact that it left from this course is due solely to a maneuver by the commander that was unapproved, unauthorized and unknown to Costa," he said at an emotional press conference in Genoa.
The fact that it left from this course is due solely to a maneuver by the commander that was unapproved, unauthorized and unknown to Costa.
When a Food and Drug Administration compliance officer told Mrs. Higman that her order of Vagifem was held because it was an "unapproved" drug, she responded, "This drug might come from Turkey, however, it is in the same box, the same packaging, the same labels, the same manufacturer, Nordisk, as the outrageously priced Vagifem in the United States".
As such, it was an "unapproved drug," and an IND was therefore required of any doctor treating a patient using FMT.
49 53 Even though all the anti-obesity agents sampled in this survey are unapproved in Japan, it is possible that anyone can procure these items without declaring the actual contents during shipping.
The Food and Drug Administration found that its "nanotainers" used to collect blood were unapproved medical devices.
In court papers, the FDA said it considers the devices, also known as e-cigarettes, to be unapproved drug-delivery gadgets.
In case it was not obvious, this is a Vladimir Putin-approveventent — high-profile gatherings like this one that are unapproved by Putin unhappen in Russia.
"These are unapproved drugs for unapproved uses and we can't guarantee consumers' safety," said Karen Riley, an F.D.A. spokeswoman.
But anti-abortion groups argue that the off-label uses are unapproved and more dangerous.
