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American Academy of Pediatrics — Maryland

Cigar Industry, FDA Due Back in D.C. Court Tomorrow

The cigar industry and the U.S. Food & Drug Administration will meet in virtual federal court tomorrow afternoon to discuss FDA’s plans to defer premium...
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12 Thoughts: FDA Wants to Reevaluate How to Regulate Premium Cigars

By Sept. 8, 2020 cigar manufacturers and others will have to submit documentation to the U.S. Food & Drug Administration (FDA) for premarket approval to...
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FDA Tells Court It Intends to Delay Substantial Equivalence for Premium Cigars, Research Premium Cigars

The U.S. Food & Drug Administration (FDA) intends on re-evaluating how it goes about regulating premium cigars, specifically, researching the potential health effects of smoking...
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Federal Appeals Court Rejects Cigar Industry’s Appeal to Move Substantial Equivalence Deadline to August 2021

The substantial equivalence deadline will not be moving back to August 2021. A three-judge panel of the U.S. Court of Appeals for the Fourth Circuit...
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FDA’s Substantial Equivalence Deadline Delayed Until Sept. 9, 2020

Cigar companies will not have to submit substantial equivalence until Sept. 9, 2020. After weeks of procedural legal functions, an agreed-upon 120-day delay of the...
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Appeals Court Gives Green Light for FDA Substantial Equivalence Delay to September

As expected, a federal appeals court will allow for a 120-day delay of FDA’s substantial equivalence deadline—currently set for May 12—due to the coronavirus COVID-19...
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Eight Cigar Companies & Two Cigar Trade Groups Seek Indefinite Delay of FDA Substantial Equivalence Due to Coronavirus

A new motion has been filed in one of the lawsuits related to the U.S. Food & Drug Administration’s (FDA) regulation of cigars, this time...
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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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Appeals Court Moves FDA Cigar Lawsuit Hearing to Video Conference Due to Coronavirus (Update)

A key court hearing regarding the cigar industry’s lawsuit over regulations by the U.S. Food & Drug Administration (FDA) has been moved from a courtroom...
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Appeals Court Denies Motion to Stay May 2020 Substantial Equivalence, Schedules Appeal Hearing for March 18

The U.S. Court of Appeals for the Fourth Circuit has denied a motion by cigar trade groups to grant a stay on the May 12, 2020...
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