Archive for the 'Documents' Category

CIVIL DOCKET FOR PHILIP MORRIS USA INC. et al v. FDA, Jun 20, 2016

Thursday, June 23rd, 2016

EXCERPT:
06/20/2016 42 TRANSCRIPT OF MOTION HEARING PROCEEDINGS before Judge Amit P. Mehta held on June 9, 2016; Page Numbers: 1-94. Date of Issuance: June 20, 2016. Court Reporter/Transcriber: William Zaremba; Telephone number: (202) 354-3249. Transcripts may be ordered by submitting the Transcript Order Form.
END EXCERPT

DOCKET for NICOPURE LABS, LLC v. FDA et al, Jun 21-23, 2016

Thursday, June 23rd, 2016

EXCERPT:
MINUTE ORDER. Two cases filed in this Court, Right to be Smoke-Free Coalition v. FDA, No. 16-cv-1210, and Nicopure Labs, LLC v. FDA, No. 16-cv-878, challenge the FDA’s final rule “Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; […]

DOJ APPEAL: CLERK’S ORDER filed scheduling oral argument, June 8, 2016

Thursday, June 9th, 2016

The PDF is Here
EXCERPT:
It is ORDERED, on the court’s own motion, that this case be scheduled for oral argument on September 13, 2016, at 9:30 A.M. The composition of the argument panel willusually be revealed thirty days prior to the date of oral argument on the court’s web site atwww.cadc.uscourts.gov.
The time and date of […]

NICOPURE v FDA: PROTECTIVE ORDER, Jun 8, 2016

Thursday, June 9th, 2016

The PDF is Here
EXCERPT:
This Order shall govern the disclosure, handling, and use of the following documents and other information in the administrative record for this case, which are hereinafter referred to as “Protected Information”:
. . .
All information that is derived from Protected Information, even […]

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

Thursday, June 9th, 2016

EXCERPT:
06/08/2016 15 SCHEDULING ORDER. Plaintiff’s motion for summary judgment shall be filed by June 24, 2016. Defendants’ opposition to plaintiff’s motion, combined with any cross-motion, which shall be supported by a single memorandum of points and authorities, shall be filed by July 19, 2016. Plaintiff’s reply in support of its motion, and opposition to defendants’ cross-motion, […]

PHILIP MORRIS v FDA: PLAINTIFFS’ NOTICE OF SUPPLEMENTAL AUTHORITY, Jun 7, 2016

Tuesday, June 7th, 2016

The PDF is Here
EXCERPT:
Plaintiffs respectfully submit this Notice regarding U.S. Army Corps of Engineers v. Hawkes Co., No. 15-290, 578 U.S. __ (May 31, 2016) . . .
In Hawkes, the U.S. Supreme Court held that a jurisdictional determination by the U.S. Army Corps of Engineers that property contains “waters of the United States”—and is […]

PHILIP MORRIS v FDA: DOCKET 6/6-6/7/16

Tuesday, June 7th, 2016

06/06/2016 MINUTE ORDER: Pursuant to Local Civil Rule 7(n), the parties should have filed a jointly prepared appendix of the administrative record in this case. It appears from the docket that they have not done so. Accordingly, a joint appendix shall be filed on or before June 8, 2016, at 12:00 p.m. Signed by Judge […]

Nicopure v FDA: [PROPOSED] PROTECTIVE ORDER, Jun 6, 2016

Tuesday, June 7th, 2016

The PDF is Here
EXCERPT:
5. Protected Information may be used only for the purposes of litigating this civil action and any appeals thereof. Except as provided in Paragraph 6, no person who obtains access to Protected Information pursuant to this Order shall disclose those documents or that information without either the prior, express, written consent […]

NICOPURE v. FDA: JOINT MOTION FOR ENTRY OF PROTECTIVE ORDER, Jun 6, 2016

Tuesday, June 7th, 2016

The PDF is Here
EXCERPT:
3. The administrative record contains over 135,000 comments. FDA estimates that more than 10,000 of those are web-based comments from individual consumers, many of which contain personally identifying information, such as names and e-mail addresses, in the “submitter information” field. Although this identifying information is not disclosed online, it appears in […]

DOCKET for NICOPURE LABS, LLC v. FDA et al, May 12-Jun 7, 2016

Tuesday, June 7th, 2016

The PDF is Here
EXCERPT:
06/06/2016 12 Joint MOTION for Protective Order by SYLVIA MATHEWS BURWELL, ROBERT CALIFF, FOOD AND DRUG ADMINISTRATION . . .
06/06/2016 MINUTE ORDER denying without prejudice 12 Joint Motion for Protective Order. While the Court is prepared otherwise to approve the proposed Joint Motion for Protective Order, it will not sign […]