Today, the U.S. Food and Drug Administration issued a proposed rule to set forth requirements related to the content, format and FDA’s review and communications procedures for premarket tobacco product applications (PMTAs) as part of the agency’s continued commitment to its oversight of e-cigarettes and other tobacco products. When finalized, this proposed rule will help to ensure that PMTAs contain sufficient information for evaluation such as details regarding the physical aspects of a tobacco product and information on the product’s potential public health benefits and harms. It also would codify the procedures by which the agency would review PMTAs and establish the requirements for manufacturers to maintain records related to the legal marketing status of their tobacco products.
“Our review of premarket product applications will help evaluate the public health benefits and harms of a tobacco product to ensure that those authorized for marketing are appropriate for the protection of public health. This will include understanding the likelihood that those who do not use tobacco products – such as kids – will start using them, as well as ...
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