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Premarket review is not required if the new product has only minor modifications from a preexisting product (which exempts it from requiring a substantial equivalence determination)

The IQOS is operated by a battery-powered heating device with a heating blade that is inserted into a HTP specific tobacco unit (heatsticks or HTP sticks) containing processed tobacco leaf 4, 5

Further, there were increases in patients use of counseling (5 percent to 12 percent), cessation of medications (6 percent to 8 percent), self-reported abstinence on the day of surgery (21 percent to 29 percent), and decreases in surgical complications (18 percent to 12 percent), but pre-to-post differences were not statistically significant

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That the crime was premeditated also seems certain

In: Broaddus VC, Mason RJ, Ernst JD, et al, eds