Today, FDA finalized two foundational rules for the premarket review

FDA Marks Historic Public Health Milestone with Finalization of Two Key Rules Today, FDA finalized two foundational rules for the premarket review of new tobacco products. These final rules provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. Both of these final rules are effective 30 days after publication in the Federal Register. The finalization of these rules helps ensure that all PMTAs and SE Reports that begin scientific review contain the basic information the agency needs to determine whether the new tobacco products meet the relevant premarket requirements to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. FDA will continue to work on a separate rule for MRTP applications. That rule, when final, will provide details for those who seek to market a tobacco product as modified or lower risk, including how to organize and submit an MRTP application. The agency will also continue efforts to assist industry in complying with federal tobacco regulations through meetings, webinars and guidance documents.

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