TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 012
Equivalence testing in demonstrating substantial equivalence for new tobacco products
(1) RAI Services Company, Winston Salem, NC, USA; (2) Naxion, Philadelphia, PA, USA
Under Section 905j of the Tobacco Control Act, manufacturers must submit reports to the FDA to demonstrate that a new tobacco product is substantially equivalent (SE) to a “predicate product.” Demonstrating equivalence with traditional statistical...