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Judge Leon applied strict scrutiny to the warning labels, meaning that the FDA had to show that its rule was narrowly tailored to achieve a compelling government interest. He applied this standard because the warning labels are compelled speech of not simply purely factual and uncontroversial information. The court said that if the mandated disclosure had been only of factual and uncontroversial information, then it would have been subjected only to the reasonable relationship test set out in the Supreme Courts Zauderer decision

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Koplow said some applications still require additional information from companies before final decisions can be made, but is occurring at an expedited pace. More direct communication with applicants during the review process has also helped companies respond more quickly to requests for missing information, Koplow said

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Potential incompatibility: Proprietary connections may not be compatible with devices from other brands or models, preventing cross-compatibility and limiting the flexibility to switch between different cartridges and batteries