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Pfizer DTC Hearing Abstract

FDADocs 5/12/2008 | 0 (0) | 17 | 0 | 0 | English

PFIZER DTC HEARING ABSTRACT Advancing Public Health Through Effective—Accessible, Understandable, and Relevant-- Consumer Health Communication Too many Americans who need medical help still don’t receive it. This leads to unnecessary suffering and high-cost, acute-care medical interventions. Accessible and motivating (i.e. understandable and releva  ... more>>

ROTARIX Rotavirus Vaccine Live Oral

FDADocs 5/12/2008 | 0 (0) | 21 | 0 | 0 | English

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ROTARIX safely and effectively. See full prescribing information for ROTARIX. ROTARIX® (Rotavirus Vaccine, Live, Oral) Oral Suspension Initial U.S. Approval: 2008 ----------------------------INDICATIONS AND USAGE --------------------ROTARIX is a  ... more>>

June Pre Market Notification Letter

FDADocs 5/12/2008 | 0 (0) | 15 | 0 | 0 | English

CHR1sPPHER WEISBERG, EA. ATTORNEYS AT LAW June IO,2002 Division of Standardsand Labeling,Regulations Office of Nutritional Products, Labeling, and Dietary Supplements (HFS-820) Center For Food Safety and Applied Nutrition FoodandDrugAdminis~~i0q:.. : :i,: .il,. ,z.~:,sz,.., .-.,I( .ci4; “,a,,‘ ., fT z-7:,1 ., ( -, .,:‘ ,)I,,, %1 5 100 Paint Branch  ... more>>

Section Toxicological tests of VasoCleaner in Mice and Rats

FDADocs 5/12/2008 | 0 (0) | 12 | 0 | 0 | English

Pan Vital Inc Department of R&D New York, NY 10032 725 West 172 Street Tel: 212-928-0373 SECTION 2 Toxicological tests of V’ hsoChmzer’ ~ File#l in Mice and Rats provides the toxicological data of VasoCZeanerm in Mice and Rats. The toxicological studies were carried out at Beijing Medical University of Chinese Medicine, Medicine Research and Te  ... more>>

Report on toxicity test of Xiwang capsule

FDADocs 5/12/2008 | 0 (0) | 12 | 0 | 0 | English

Report on toxicity test of Xiwang capsule AmqUA & lK+ r@i 39 PZ 25 Xiwang capsule is a new selenium-contained functional food, the chemical form of its selenium, which is called nanometerselenium,is different from inorganic selenium and organic selenium. Comissionedby the Departmentof Leaf Protein, Hefei Economy and Technology College, an acute  ... more>>

August letter to Christopher Weisberg P A

FDADocs 5/12/2008 | 0 (0) | 16 | 0 | 0 | English

-r : ,p”“““+~ p* ,/ . . x+* # 0 Au62om :. DEPARTMENT OF HEALTH AND HUMAk SERVICES Pubk Health Service Food and Drug Administration College Park, MD I Jason S. Crush Christopher & Weisberg, P.A Attorneys at Law 200 East Las Olas Boulevard Suite 2040 Fort Lauderdale, Florida 33301 Dear Mr. Crush: This letter is in responseto your notification, d  ... more>>

Transmittal Letter and July letter to Christopher Weisberg P A

FDADocs 5/12/2008 | 0 (0) | 13 | 0 | 0 | English

x,i I L. Public Health Service Food and Drug Administration DFP~TM.ENT OF HEALTH & HUMAN SERVICES ,. I.”,,-Memorandum: , ,c.,. *I- \~. ?‘ 7 Date: From: a3, &a03 Chemist, Division of Dietary Supplement Programsand Compliance, Office of Nutritional Products, Labeling and Dietary Supplements,HFS-8 10 75Day Premarket Notification of New Dietary I  ... more>>

November New Dietary Ingredient Submission

FDADocs 5/12/2008 | 0 (0) | 9 | 0 | 0 | English

NAN0 PORT (USA) INC. 3 17 W35th Street, Apt 3FE, New York, NY 10001, USA Tel : 917-435-4423 Division of Standards& Labeling Regulations Of&e of Nutrition Products, Labeling, and Dietary Supplements @IFS-820) Center for Food Safety & Applied Nutrition Food and Drug Administration 200 C Street, NW Washington, D.C. 20204 Dear Sir, New Dietarv Ingredi  ... more>>

Pl ACUTE TOXICITY STUDY GOALS

FDADocs 5/12/2008 | 0 (0) | 6 | 0 | 0 | English

064 6 '03 FE0 25 Pl :54 ACUTE TOXICITY STUDY GOALS: Assessment of the acute toxicity of the Padina Pavonica whole extract (AP 099301) in mice. STUDY MATERIALS: Animals: 40 NMRI male mice with standard health status were used. Average weight was 15 g. These animals were provided by IFFA CREDO breeding farm, Domaine des Oncins, 692 10 L’ ARBRESLE  ... more>>

Memorandum subject Policy on Clinical Issues Related to Anthrax Vaccination

FDADocs 5/12/2008 | 0 (0) | 8 | 0 | 0 | English

THE ASSISTANT WASHINGTON, SECRETARY D. C OF DEFENSE 20301-1200 MEMORANDUM FOR SECRETARIES OF THE M ILITARY DEPARTMENTS CHAIRMAN OF THE JOINT CHIEFS OF STAFF UNDER SECRETARIES OF DEFENSE ASSISTANT SECRETARIES OF DEFENSE GENERAL COUNSEL, DEPARTMENT OF DEFENSE INSPECTOR GENERAL, DEPARTMENT OF DEFENSE DIRECTORS OF DEFENSE AGENCIES COMMANDANT OF TH  ... more>>

Memorandum subject Reactions to Vaccines

FDADocs 5/12/2008 | 0 (0) | 6 | 0 | 0 | English

DEPARTMENT OF THE ARMY OFFICE O F THE SURGEON GENERAL 5108 LEESSURG PIKE FALLS CHURCH VA 220914258 REPLY Yo ATTamDwoF DASGZA MEMORANDUM SUBJECT: FOR SEE DlSTRlBUTIUN Reactions to Vaccines 1. During recent Congressional hearings before the House Committee on Government Reform, several individuals, many of them active duty, alleged harm from t  ... more>>

   
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