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

December 16, 2015 1:11 am by Gene Borio

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: Responses to Frequently Asked Questions

D Draft Guidance, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions

E Letter from James E. Dillard, III, Altria Client Services re: Docket No. FDA-2011-D-0147 (76 Fed. Reg. 55,927 (Sept. 9, 2011)) – Comments on the “Draft Guidance for Industry and FDA Staff: Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions”

END EXCERPT

FULL TEXT:

Case 1:15-cv-01590-APM Document 33-1 Filed 12/14/15 Page 1 of 1

TABLE OF CONTENTS

Portions of Administrative Record Cited in Plaintiffs’ Motion for Recusal and Memorandum of Law in Support of Recusal, Philip Morris USA Inc. v. FDA, No. 1:15-cv-1590

Exhibit Document Title/Description Date A.R. Page Numbers

A Guidance for Industry, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 2)
9/8/2015
001-037

B Guidance for Industry, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
5/2015
038-060

C Guidance for Industry, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
3/4/2015
061-082

D Draft Guidance, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
9/2011
083-095

E Letter from James E. Dillard, III, Altria Client Services re: Docket No. FDA-2011-D-0147 (76 Fed. Reg. 55,927 (Sept. 9, 2011)) – Comments on the “Draft Guidance for Industry and FDA Staff: Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions”
11/8/2011
164-178

F Letter from American Cancer Society Cancer Action Network, American Heart Association, et al. re: Docket No. FDA-2011-D-0147
11/8/2011
179-203

G Letter from American Cancer Society Cancer Action Network, American Heart Association, et al. re: Docket No. FDA-2010-D-0635, FDA-2011-D-0147, and FDA-2010-N0646, Comments in Response to Submissions of Other Parties on Demonstrating Substantial Equivalence for Tobacco Products
4/4/2013
214-295

H Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Availability, 76 Fed. Reg. 55927
9/9/2011
478-479

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