PMP S.A. Module 7: Scientific Studies and Analyses
The FDA filed for scientific review three Modified Risk Tobacco Product (MRTP) Applications from Philip Morris Products S.A. (PMP S.A.) for its IQOS system and three types of Heatstick products on May 24, 2017.
7.3.1 Clinical Studies (added November 28, 2017; updated January 24, 2018)
- 7.3.1 Summary of Clinical Studies (PDF – 251 KB)
- 7.3.1 Tabulated Index of Clinical Studies (PDF – 247 KB)
- 01 PK01EU (.zip - 411 MB)
- Study Report: Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2
- 02 PK02JP (.zip - 541 MB)
- Study Report: Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2
- 03 REXC03EU (.zip - 1.0 GB)
- Study Report: Reduced Exposure Study in Smokers Using Tobacco Heating System 2.2 with 5 Days in a Confinement Setting
- 04 REXC04JP (.zip - 1.1 GB)
- Study Report: Reduced Exposure Study Using Tobacco Heating System 2.2 with 5 Days in a Confinement Setting
- 05 PK05JP (.zip - 487 MB)
- Study Report: Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol
- 06 PK06US (.zip - 581 MB)
- Study Report: Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol
- 07 REXA07JP (.zip - 515 MB) (updated January 24, 2018)
- Study Report: Reduced Exposure Study Using THS 2.2 Menthol with 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
- 08 REXA08US (.zip - 723 MB) (updated January 24, 2018)
- Study Report: Reduced Exposure Study Using THS 2.2 Menthol with 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting
- Safety Update Report THS – Regular (.zip - 155 MB)
- Safety Update Report THS – Menthol (.zip - 155 MB)
- Safety Update Report THS – Regular and Menthol (.zip - 9 MB)
- Safety Summary Report PBA07 – Regular and Menthol (.zip - 3 MB)
- Report: Passive Safety Surveillance for Perception and Behavior Assessment Study – THS-PBA-07-US
- THS Additional Safety Data Report – Regular and Menthol (.zip - 24 MB)
7.3.2 Perception and Behavior Assessment (PBA) Studies (added November 28, 2017; updated January 24, 2018)
- 7.3.2 Summary of Perception and Behavior Assessment studies
- 7.3.2 Tabulated Index of Perception and Behavior Assessment studies
- PBA01Sum (.zip - 36 MB)
- Summary Document: PBA01 ‒ Scales Development and Validation Project
- PBA02 (.zip - 348 MB) (updated January 24, 2018)
- Study Report: Qualitative Study to Develop THS 2.2 Hypothetical Product Messages
- PBA02 Summary: Qualitative Study to Develop THS 2.2 Hypothetical Product Messages
- PBA03 (.zip - 140 MB)
- Study Report: Study to Quantitatively Assess THS 2.2 Potential Messages
- PBA03 Summary: Study to Quantitatively Assess THS 2.2 Potential Messages
- PBA04 (.zip - 54 MB)
- Study Report: Qualitative Study to Develop THS 2.2 Potential Label, Labeling and Marketing Material
- PBA04 Summary: Qualitative Study to Develop THS 2.2 Potential Label, Labeling and Marketing Material
- PBA05REC (.zip - 106 MB)
- Study Report: Quantitative Assessment of THS 2.2 Label, Labeling and Marketing Material with Reduced Exposure Claims
- PBA05REC Summary: Quantitative Assessment of THS 2.2 Label, Labeling and Marketing Material with Reduced Exposure Claims
- PBA05RRC (.zip 114 MB)
- Study Report: Quantitative Assessment of THS 2.2 Label, Labeling, and Marketing Material with Reduced Risk Claims
- PBA05RRC Summary: Quantitative Assessment of THS 2.2 Label, Labeling, and Marketing Material with Reduced Risk Claims
- PBA05RRC2 (.zip - 93 MB)
- Study Report: Second Quantitative Assessment of THS 2.2 Label, Labeling, and Marketing Material with Reduced Risk Claims
- PBA05RRC2 Summary: Second Quantitative Assessment of THS 2.2 Label, Labeling, and Marketing Material with Reduced Risk Claims
- PBA06 (.zip - 326 MB)
- Study Report: Usability and Comprehension Study of THS 2.2 Instructions for Use Within Adult Smokers
- PBA06 Summary: Usability and Comprehension Study of THS 2.2 Instructions for Use Within Adult Smokers
- PBA07 (.zip 1.2 GB)
- Study Report: Actual Use Study of THS 2.2
- PBA07 Summary: Actual Use Study of THS 2.2