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Previously, the F.D.A. could only negotiate with a drug's manufacturer to change the label.
Dr. Woodcock concluded that the F.D.A. would take no action to change the label.
It is then up to the agency to decide whether to change the label.
Under the current system, brand-name manufacturers can change the label if they receive important new information about their drug.
The F.C.C. has the legal authority to change the label, as long as it can provide a good reason.
"We stand by our original decision to change the label, and remain convinced that this is the best means for the international conservation of dolphin populations".
Similar(30)
It can't even be arsed to prominently change the labels.
There is another impetus for companies to move to change the labels before the regulators do -- recalls.
Marks & Spencer said it would change the labelling of some toys badged "boy's stuff" and "Li'l Miss Arty".
Areas of land were given different labels – urban, agricultural, natural – but the authorities could change the labels so an area that was once agricultural could be built on.
The Food and Drug Administration has ordered Amgen to change the labels for its flagship anemia drugs in a way that could further restrict their use in treating patients with cancer.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com