On Dec. 21, FDA issued draft guidance for industry entitled
"Validation and Verification of Analytical Testing Methods Used for
Tobacco Products."
The draft guidance, when finalized, would provide information
and recommendations related to the validation and verification of
analytical test methods, including analytical testing of tobacco product
constituents, ingredients, and additives, as well as stability testing of
tobacco products. This draft guidance would help industry produce more
consistent and reliable analytical data used to support regulatory
submissions for tobacco products, such as premarket tobacco product
applications (PMTAs) and substantial equivalence (SE) reports.
FDA requests comments beginning tomorrow (Dec. 22) through
Feb. 22, 2022, including scientific and other information, concerning the
recommendations set forth in the draft guidance.
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