10:28 → 15:17(4m 49s)
Matthew Farley (Director, Office of Science, CTP) opened the roundtable, set the agenda and said the goal is twofold: explain scientific evidence FDA needs for PMTA APPH determinations and solicit small-manufacturer feedback on obstacles in the PMTA process.
FDA Center for Tobacco Products Office of Science hosted a roundtable with small ENDS manufacturers, researchers and agency scientists to discuss evidence needs for premarket tobacco product applications (PMTAs), focusing on product characterization, manufacturing controls, pharmacology (abuse liability), adult-benefit studies and toxicology (ELCR). Participants pressed FDA for clearer standards, more transparency and ways to reduce cost and uncertainty for small businesses.
