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Headlines Tagged with FDASuit 356 headlines found

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Tobacco companies get partial win in FDA labeling fight

Tuesday vacated part of an FDA directive stating tobacco companies may need the agency's clearance to market products with significant labeling modifications, such as a change in color or logo. However, Mehta said that the agency could require clearance
Reuters
added Aug 18, 2016 04:12
10 Views

FDA Guidance Partially Undone In Tobacco Labeling Suit ($$)

At heart of the issue was whether changing a current product’s label enough to make it “distinct” from the former label makes the product itself a new tobacco product subject to FDA approval through its substantial equivalence review process, the court s
Law360
added Aug 18, 2016 04:00
10 Views

Tobacco companies get partial win in U.S. FDA labelling fight

Tuesday vacated part of an FDA directive stating tobacco companies may need the agency's clearance to market products with significant labelling modifications, such as a change in colour or logo. However, Mehta said that the agency could require clearanc
Yahoo! Finance
added Aug 17, 2016 18:47
8 Views

Federal judge rules label change does not make for new tobacco product

A federal judge ruled Tuesday that [FDA] cannot consider that a label change for a tobacco product makes it a new product for regulatory purposes. However, Judge Amit Mehta also ruled that changing the quantity of the product in packaging does constitute
Winston-Salem (NC) Journal
added Aug 17, 2016 18:42
4 Views

TAA Donates $50000 To FDA Lawsuit

Tobacconists' Association of America...has contributed $50,000 to be split equally among the legal funds of the International Premium Cigar & Pipe Retailers association and the Cigar Rights of America. The two organizations, along with the Cigar Associat
Cigar Aficionado
added Aug 17, 2016 18:51
14 Views

PHILIP MORRIS v FDA: MEMORANDUM OPINION, Aug 16, 2016

Defendants’ Motion to Dismiss is denied. Defendants’ Motion for Summary Judgment and Plaintiffs’ Motion for Summary Judgment are granted in part and denied in part. This matter is remanded to the agency for further proceedings, as needed.
Tobacco On Trial
added Aug 17, 2016 06:14
4 Views

DOCKET FOR PHILIP MORRIS USA INC. et al v. FDA, Aug 16, 2016

44 ORDER. The court (1) denies 29 Defendants’ Motion to Dismiss, (2) grants in part and denies in part 29 Defendants’ Motion for Summary Judgment, and (3) grants in part and denies in part 21 Plaintiffs’ Motion for Summary Judgment. This matter is remande
Tobacco On Trial
added Aug 17, 2016 05:55
18 Views

NICOPURE v FDA: Notice of Errata by Clive Bates and Fifteen others, Aug 8, 2016

Amici are Philip Alcabes...Edward Anselm...Ernest Drucker...Konstantinos Farsalinos....William T. Godshall... Jacques Le Houezec...Bernd Mayer...Jeff Nesbit...Joel L. Nitzkin...Riccardo Polosa...Gilbert L. Ross... Sally L. Satel...Michael B. Siegel...Andr
Tobacco On Trial
added Aug 9, 2016 22:08
8 Views

NICOPURE v FDA: BRIEF OF AMICI CURIAE CLIVE BATES AND FIFTEEN OTHERS, Aug 8, 2016

Deeming Rule overstates benefits and ignores a major category of cost. The analysis is fundamentally flawed and not a sufficient justification for the Deeming Rule. It is the view of the Amici that applying the Deeming Rule to ENDS is likely to cause more
Tobacco On Trial
added Aug 9, 2016 21:35
6 Views

DOCKET for NICOPURE LABS v. FDA et al, Aug 8, 2016

08/08/2016 MINUTE ORDER granting Clive Bates’s unopposed 38 motion for leave to file an amicus brief. . . . 08/08/2016 41 AMICUS BRIEF by CLIVE BATES. (jf) (Entered: 08/09/2016)
Tobacco On Trial
added Aug 9, 2016 21:17
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