TSRC, Tob. Sci. Res. Conf., 2023, 76, abstr. 26
Electronic trial master file: an important step in documenting clinical trial data used to support a premarket tobacco product application
RAI Services Company, Winston-Salem, NC, USA
Before introducing a new tobacco product to the US market, companies are required to submit a Premarket Tobacco Product (PMTA) application to the FDA and receive authorization. This application comprises data generated across multiple scientific...