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Department of Health and Human Services

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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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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CRA, PCA Petition HHS/FDA to Delay May 2020 Substantial Equivalence Deadline

Two cigar trade groups have asked FDA to delay the May 2020 substantial equivalence submission deadline due to the coronavirus COVID-19 pandemic. If it doesn’t...
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Alex Azar Sworn In as HHS Secretary

Alex Azar II is the new director of Health and Human Services (HHS). He was sworn in earlier today following a Senate confirmation vote of...
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Alex Azar Nominated as HHS Secretary

Alex Azar II has been nominated to serve as the next secretary of the U.S. Health and Human Services Department (HHS). He previously served in...
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HHS Secretary Tom Price Resigns

Tom Price has resigned as secretary of Health and Human Services, the federal government branch that oversees the U.S. Food & Drug Administration (FDA). His...
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Tom Price Confirmed as HHS Secretary

Early Friday morning Rep. Tom Price was confirmed as secretary of Health and Human Services by a vote of 52 to 47. Price, an orthopedic surgeon...
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