TSRC, Tob. Sci. Res. Conf., 2016, 70, abstr. 74
How to fulfill statutory requirements on product related health information
PSI International, Inc., Fairfax, VA, USA
In 2009 Congress passed and President Obama signed the Family Smoking Prevention and Tobacco Control Act granting FDA authority over select tobacco products. The three Statutory Pathways for new products are Substantial Equivalence Reports, Premarket...