Archive for December, 2015

6180: Attachment 1: Errata Certification of Compliance with Order #28 Remand, Dec 28, 2015

Monday, December 28th, 2015

EXCERPT:
The University of California, San Francisco certifies that the funds it received in connection with Order #28 Remand: consent order between the United States, the public health interveners, and Lorillard Tobacco Company concerning document disclosure obllgatlons under Order #1015 were used to improve access to the functionality of the Legacy Tobacco Documents Library, and for […]

6179: Attachment 1: Exhibit Certification of Compliance with Order #27 Remand, Dec 28, 2015

Monday, December 28th, 2015

EXCERPT:
The University of California, San Francisco certifies that the funds it received in connection with Order #27 Remand: consent order between the United States, the public health interveners, Philip Morris USA Inc., Altria Group, Inc., and R.J. Reynolds Tobacco Company concerning document disclosure obligations under Order #1015 were used to improve access to the functionality […]

DOCKET for USA v. PHILIP MORRIS USA, et al Dec. 28, 2015

Monday, December 28th, 2015

12/28/2015 6179 NOTICE of Filing Certification by REGENTS OF THE UNIVERSITY OF CALIFORNIA re 5953 Order, 5733 Order (Attachments: # 1 Exhibit Certification of Compliance with Order #27 Remand)(Leff, Peter) (Entered: 12/28/2015)
12/28/2015 6180 NOTICE of Filing Certification by REGENTS OF THE UNIVERSITY OF CALIFORNIA re 5733 Order (Attachments: # 1 Errata Certification of Compliance with Order #28 […]

SANTA FE: DOCKET for Rothman v. Santa Fe Natural Tobacco Company, Dec. 16-18

Thursday, December 17th, 2015

EXCERPT:
12/16/2015 13 FILING ERROR - DEFICIENT DOCKET ENTRY - MOTION for Noel John Francisco to Appear Pro Hac Vice
. . .
12/17/2015 >>>NOTICE REGARDING DEFICIENT MOTION TO APPEAR PRO HAC VICE. Notice to RE-FILE Document No. 13 MOTION for Noel John Francisco to Appear Pro Hac Vice ….The filing is deficient for the following reason(s): […]

MO v. FDA: Portions of Administrative Record Cited in Plaintiffs’ Motion for Recusal and Memorandum of Law in Support of Recusal, Dec. 14, 2015

Wednesday, December 16th, 2015

The PDF is Here
EXCERPT:
A Guidance for Industry, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 2)
B Guidance for Industry, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
C Guidance for Industry, Demonstrating the Substantial Equivalence of a New Tobacco Product: […]

MO v. FDA: PLAINTIFFS’ NOTICE REGARDING PORTIONS OF ADMINISTRATIVE RECORD CITED IN THEIR MOTION FOR RECUSAL, Dec. 14, 2015

Wednesday, December 16th, 2015

The PDF is Here
EXCERPT:
Pursuant to this Court’s December 11, 2015 Order, Plaintiffs respectfully submit the portions of the administrative record cited in Plaintiffs’ Motion for Recusal and Memorandum of Law in Support of Recusal. ECF No. 25. Those materials are attached as Exhibits A-H.
END EXCERPT

PHILIP MORRIS USA v. FDA: DECLARATION OF ANN SIMONEAU, Dec. 8, 2015

Sunday, December 13th, 2015

The PDF is Here
EXCERPT:
1. I am currently serving as Director of the Office of Compliance and Enforcement (OCE) in the United States Food and Drug Administration’s Center for Tobacco Products (CTP) . . .
4. FDA’s Regulatory Procedures Manual (RPM), Chapter 10, § 10-2-2 (Prior Notice), provides that “a basic principle of FDA’s enforcement policy […]

PHILIP MORRIS USA v. FDA: DECLARATION OF DAVID L. ASHLEY [REDACTED] Dec. 8, 2015

Sunday, December 13th, 2015

The PDF is Here
EXCERPT:
1. I am the Director of the Office of Science in the United States Food and Drug Administration’s Center for Tobacco Products in Silver Spring, Maryland. . . . As Director of the Office of Science, I am familiar with FDA’s review and authorization of substantial equivalence (SE) reports . . […]

PHILIP MORRIS v. FDA: DEFENDANTS’ MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF THEIR MOTION TO DISMISS, OR IN THE ALTERNATIVE, FOR SUMMARY JUDGMENT, AND IN OPPOSITION TO PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT, Dec. 8, 2015

Sunday, December 13th, 2015

The PDF is Here
EXCERPT:
Plaintiffs have filed a facial challenge to the guidance document, contending that FDA has misinterpreted the statute, acted arbitrarily in issuing the guidance, and, with respect to label changes, violated their First and Fifth Amendment rights.
As we show below, Plaintiffs may not obtain review of the guidance document. A guidance document […]

DOCKET for MO v. FDA Dec. 8-11, 2015

Thursday, December 10th, 2015

PHILIP MORRIS USA INC. et al v. UNITED STATES FOOD AND DRUG ADMINISTRATION et al
Assigned to: Judge Amit P. Mehta
Case: 1:15-cv-00544-APM
Cause: 05:551 Administrative Procedure Act
Date Filed: 09/30/2015
Jury Demand: None
Nature of Suit: 899 Administrative Procedure Act/Review or Appeal of Agency Decision
Jurisdiction: U.S. Government Defendant
Date Filed # Docket Text
12/08/2015 29 MOTION to Dismiss or, in the Alternative, Motion for […]