🚬FDA Correction Notice on Tobacco Research Development Meetings
The document is a correction to a previous notice by the Department of Health and Human Services concerning meetings with industry and investigators related to the research and development of tobacco products. This correction clarifies the subject line for improved accuracy in communication.
Learn More🏭FDA Plans Information Collection for Tobacco Industry Meetings
The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in FDA's guidance titled "Meetings with Industry and Investigators on the Research and Development of Tobacco Products (Revised)."
Learn More❌FDA Withdraws Direct Final Rule on Regulatory Hearing Provisions
The Food and Drug Administration (FDA or Agency) published in the Federal Register of September 20, 2024, a direct final rule amending the Scope section of our regulation that provides for a regulatory hearing before the Agency. The comment period closed December 4, 2024. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.
Learn More📊FDA Guidance on Analytical Testing Methods for Tobacco Products
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Validation and Verification of Analytical Testing Methods Used for Tobacco Products." The guidance provides 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 guidance is intended to help industry produce more consistent and reliable analytical data used to support regulatory submissions for finished tobacco products. This guidance finalizes the draft guidance of the same title issued in December 2021.
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