By: Angela Garrity
The FDA’s Center for Tobacco Products (CTP) released scientific review policy memoranda today aims to assist reviewers with the evaluation of tobacco product applications. The memos are meant to serve as a useful reference, however, should not be used as a manual for preparing tobacco product applications. The memos represent the FDA’s approach at the time that the memos were written.
The memos are broken down by the following categories: General, Chemistry/Toxicology, Engineering, Social Science, Behavioral Clinical Pharmacology and Microbiology.
Please note that the information contained is subject to change based on policy advances, regulatory framework and regulatory science. It is non-binding on the FDA nor the public.