Tag

substantial equivalence

Court Signals FDA Substantial Equivalence Deadline Will be Delayed Until Sept. 9

While not yet official, the deadline for cigar companies to submit substantial equivalence reports to the U.S. Food & Drug Administration (FDA) will almost certainly...
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FDA Asks Court to Delay Substantial Equivalence Deadline Until Sept. 9, 2020 Due to Coronavirus

The U.S. Food & Drug Administration (FDA) has asked a federal court to delay the substantial equivalence deadline—currently set for May 12, 2020—due to the...
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Court Tells FDA to Make a Decision Regarding Substantial Equivalence Extension This Week or Risk Trial

The U.S. Food & Drug Administration (FDA) will have until this Friday to grant an extension for the upcoming substantial equivalence deadline, set for May...
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Micallef Launching PredX, Trade Exchange for FDA Predicate Blends

In a world of strict FDA regulation of cigars, there will likely be some process where companies trade or sell the rights to FDA-approved blends...
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FDA Announces Proposed Record-Keeping Rules for Substantial Equivalence

Yesterday, the U.S. Food & Drug Administration (FDA) published proposed rules for the process of applying for agency approval of e-cigarettes and vaping products. Almost...
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CRA Gives FDA Three Options for the Future of Cigar Regulation

The Cigar Rights of America (CRA), representing roughly 100 companies that are involved with the production of premium cigars, has filed its comments to the...
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Six Companies File Joint Comments Seeking Premium Cigar Exemption from FDA

Six of the world’s largest cigar companies have filed joint comments regarding the FDA’s regulation of premium cigars, advocating that the agency is not able...
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FDA Extends Comment Period for Revised Substantial Equivalence Process to July 17

The U.S. Food & Drug Administration (FDA) has announced a 30-day extension to its current request for comments on how it should revise its substantial...
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FDA Plans Updated Substantial Equivalence Process for Tobacco Products

One of the many complaints cigar companies have with the FDA and the agency’s regulations on tobacco products is a lack of clarity. Nowhere is...
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