Johanna Dwyer,
...endif.....endif]> Johanna Dwyer, D.Sc. (Chair) Professor, Tufts University Schools of Medicine and.....endif]> Anthony Gaspari, M.D. Professor of Dermatology.. University of Maryland School of..
http://www.fda.gov/ohrms/dockets/ac/03/roster/3977r1.htm (score=100)

Bv Certified Mail - Return Receipt Requested
...endif]> The safety of the individual subject, and potentially ail subjects in the study.....endif]> The Form FDA 1572 Statement of Investigator did not include two clinical.....endif]> This letter is not intended to be an all-inclusive list of deficiencies with your..
http://www.fda.gov/foi/warning_letters/g3653d.htm (score=95)

Questions for the Gastrointestinal Drugs Advisory Committee
...endif]>Are the clinical trial data adequate with respect to the population with chronic.....endif]>Post-marketing cases of ischemic colitis and serious complications of diarrhea were.....endif]>Do the adverse event data from the clinical trials and post-marketing surveillance..
http://www.fda.gov/ohrms/dockets/ac/04/questions/2004-4056Q1_Draft.htm (score=92)

Issue Summary:
...endif]> The potential risk of transmission of SFV by blood transfusion is being brought to.....endif]> The topic of SFV was discussed at the December 13, 2001 BPAC meeting because of.....endif]> No evidence of transmission of SFV by human-to-human blood transfusion was found..
http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4074b1_02_topic%202.htm (score=92)

Questions for the Gastrointestinal Drugs Advisory Committee
...endif]>Are the clinical trial data adequate with respect to the population of non-IBS.....endif]>Post-marketing cases of ischemic colitis and serious complications of diarrhea were.....endif]>The incidence of diarrhea and discontinuations due to diarrhea was higher in..
http://www.fda.gov/ohrms/dockets/ac/04/questions/2004-4056Q1_Final.htm (score=91)

Response to Reviewers
...endif]>In this paper women of child-bearing age are defined as those between 18 and 45.....endif]>For purposes of applying the scenarios in the exposure assessment, the following.....endif]>Reviewers indicated that the document was clearly written for the concise form in..
http://www.fda.gov/ohrms/dockets/ac/03/briefing/4010b1-12-%20EPA.htm (score=91)

Glucosamine and Chondroitin Sulfate: Scientific Evaluation
...endif]>Maintaining the structural and functional integrity of the proteoglycan component.....endif]>Imbalanced metabolism favoring catabolism within the extracellular matrix of.....endif]>Compromise of the structural and functional integrity of the proteoglycan component..
http://www.fda.gov/ohrms/dockets/ac/04/briefing/4045b1_04_Summary%20GCSOA%20FAC.htm (score=91)

Progress Report on the Recommendations from the 2002 Food Advisory...
...endif]> To address this issue we propose to simplify the language related to this section.....endif]> Our data indicate that canned tuna is one of the most consumed commercial fish.....endif]> The current FDA advisory does not address the age of children and neither we nor..
http://www.fda.gov/ohrms/dockets/ac/03/briefing/4010b1-10.htm (score=90)

Questions for Consideration
...endif]> Please discuss the clinical significance of these and any other adverse events.....endif.....endif]> 2. A higher incidence of the following adverse events occurred in the Charité..
http://www.fda.gov/ohrms/dockets/ac/04/questions/4049q1_Questions%20for%20consideration.htm (score=89)

January 8, 2004
...endif]>Torque strength, number of rotations needed produce fracture at distal tip.....endif]>Torque test, establish that a 1:1 ratio exists for manipulation of balloon catheter.....endif]>Kink resistance, catheter will not kink when bent to a 0.5 inch diameter with..
http://www.fda.gov/ohrms/dockets/ac/04/briefing/4022b1_FDA%20Device%20Review.htm (score=89)

MINUTES
...endif]>Describe some of the specific changes in infant formula that would reasonably be.....endif]>Use of other compounds known to affect hormones, growth factors, genes, or.....endif]>Interactions affecting potential bioactivity or bioavailablility among individual..
http://www.fda.gov/ohrms/dockets/ac/02/minutes/3903m1.htm (score=89)

Guidance for Industry - Submitting Separate Marketing Applications and...
...endif]> or combination of two or more different active ingredients should be submitted in.....endif]> should be submitted in a single original application unless, for some other reason.....endif]> may require a new application to be submitted because of a change to the reference..
http://www.fda.gov/cder/guidance/5469fnl.htm (score=89)

AGENDA
...endif.....endif]> A Speaker Phone for Public Participation Will Be Provided in.. Conference Room A.....endif]> FOOD AND DRUG ADMINSITRATION.. CENTER FOR BIOLOGICS EVALUATION AND RESEARCH..
http://www.fda.gov/ohrms/dockets/ac/04/agenda/4032A1_draft.htm (score=87)

Review Summary for Plan B® Safety
...endif]>Does the product have an acceptable margin of safety as based on prior prescription.....endif]>Fifteen small studies of oral levonorgestrel for routine or occasional postcoital.....endif]>Do not take Plan B if you are allergic to levonorgestrel or any ingredient in Plan..
http://www.fda.gov/ohrms/dockets/ac/03/briefing/4015B1_12_FDA-Tab%205-1-Medical%20Officer%20Review.htm (score=87)

Center for Food Safety and Applied Nutrition
...endif]> 2. If a positive relationship has been established and shown to be causative what.....endif]> 3. What additional questions need to be addressed to adequately understand this.....endif]> Food Advisory Committee Meeting.. Additives and Ingredients Subcommittee.. <![if..
http://www.fda.gov/ohrms/dockets/ac/03/briefing/3977b1_Summary%20and%20Questions.htm (score=87)

QUESTIONS FOR FDA SCIENCE BOARD
...endif]>What kind of evaluation is appropriate to assess the effectiveness of a pilot.....endif]>As we explore which options to consider when providing nutrition information for.....endif]>Do you know of any research that would be helpful for a facilitator to assist them..
http://www.fda.gov/ohrms/dockets/ac/04/questions/4039q1_questions.htm (score=86)

Catholic Health Partners Warning Letter
...endif]>The document does not establish procedures to enable the IRB to conduct the.....endif]>Assure that the membership and quorum include at least one member whose primary.....endif]>Avoid conflict of interest in its reviews, and how the IRB will consider research..
http://www.fda.gov/foi/warning_letters/g3746d.htm (score=86)

NATIONAL MAMMOGRAPHY QUALITY ASSURANCE
...endif]> Persons with disabilities, who require assistance with special hotel.....endif]> Maryland Shuttle provides shuttle van service from Regan National, Dulles.....endif]> Service from Ronald Reagan National Airport to Gaithersburg, Maryland is available..
http://www.fda.gov/ohrms/dockets/ac/03/briefing/3953b1_GENERAL%20ATTENDANCE%20INFORMATION.htm (score=85)

PARTIVI [doc]
...endif]>Production is performed in a controlled environment that prevents an increase in.....endif]>Procedures to prevent equipment or product contamination by any substance that.....endif]>Precautions are taken to prevent contamination or cross-contamination in areas in..
http://www.fda.gov/cder/dmpq/7356_002M.htm (score=85)

Gastrointestinal Advisory Committee on Zelnorm® for Treatment of Chronic...
...endif]>Is the population studied representative of patients with chronic idiopathic.....endif]>Are the clinical trial data adequate with respect to the population with chronic.....endif]>Post-marketing cases of ischemic colitis and serious complications of diarrhea were..
http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4056B1_02_A-FDA-Zelnorm.htm (score=85)

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