Yesterday, the FDA announced a significant move towards transparency within the premarket tobacco review process. In response to stakeholder feedback and commitments made by the Center for Tobacco Products (CTP), the FDA is releasing several scientific review policy memoranda previously kept internal.
Dr. Brian King, Director of FDA’s Center for Tobacco Products, emphasized the importance of this action, stating, "We’ve heard loud and clear from stakeholders that opportunities exist to enhance the Center’s transparency."
These memos provide valuable insights into the internal considerations of regulatory science disciplines during the review of tobacco product applications. Covering topics in chemistry and toxicology, they offer a snapshot of the FDA's thinking at specific points in time.
This release marks the beginning of an ongoing effort by the FDA to provide further clarity on the premarket review process. Looking forward to reviewing future memos aligned with PMTA Module 6 Studies. Stay tuned for more updates as the FDA continues to make strides towards transparency in tobacco product regulation.
For more information and to access the newly released memos, READ HERE:
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