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Last update: November 12, 2013.
1

Cancidas - FDA Presentation Slides  

Center for Biologics Evaluation and Research (CBER)

Text Version... 7 y/o with autoimmune hemolytic anemia treated for brain and renal aspergillus fumigatus abscess developed neurologic deficits. ... fumigatus (n=1) ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

2

Abilify - FDA Presentation Slides  

Center for Biologics Evaluation and Research (CBER)

Text Version... Symptoms while on aripiprazole 2 mg daily • Symptom resolution upon discontinuation of aripiprazole ... Adderall was a concomitant medication. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

3

Evacil - FDA Presentation Slides  

Center for Biologics Evaluation and Research (CBER)

Text Version... The number of kits sold is an estimate of the number of patients ... Use increased over time: an estimated ... 22 yo female w/ fatal air embolism after ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

4

13 Orencia - FDA Presentation Slides  

Center for Biologics Evaluation and Research (CBER)

Text Version... multiple sclerosis, lymphoma, infection, dyspnea, purpura, transaminitis 15 Page 16. 16 ... Purpura: 15 year old, purpura on legs after ~ 15 months ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

5

Q&A Slides Presented FDA CDER  

Center for Biologics Evaluation and Research (CBER)

Text Version... Monte Carlo simulation predicted probability of target attainment from human population PK studies ... Monte Carlo simulations integrating patient ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

6

FDA Presentation  

Center for Biologics Evaluation and Research (CBER)

Text Version... Profile of Mood States (POMS) • State Trait Anxiety Inventory (STAI) • 16PF Personality Test Subtest for Self- Sufficiency ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

7

FDA Presentation  

Center for Drug Evaluation (CDER)

Text Version... 3.50 .001 Source: Hatsukami, Jensen, Allen, Grillo, & Bliss (1996). Journal of Consulting & Clinical Psychology, 65(1); 153-161. Page 10. ... More results from www.fda.gov/downloads/drugs/newsevents

8

March 1-2, 2012: Slides Presented at the TPSAC Meeting  

Center for Biologics Evaluation and Research (CBER)

... Scientific Advisory Committee. -. March 1-2, 2012: Slides Presented at the TPSAC Meeting. Slides Presented by the FDA. Sarah E ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/tobaccoproductsscientificadvisorycommittee

9

CCMT FDA AC Meeting Slides June 29  

Center for Biologics Evaluation and Research (CBER)

Text Version... Course layouts standardized and randomized to prevent learning effect ... Evaluate correla+on with visual func+on tests (VA & VF) and pa+ent ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

10

August 13, 2009: Slides from Scheduled Presentations  

Center for Biologics Evaluation and Research (CBER)

... Menu Skip to Section Content Menu Skip to Common Links. ... MB); Slides: FDA Information Need: Data on Consumer Knowledge during Foodborne ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/riskcommunicationadvisorycommittee

11

April 30, 2013: Slides Presented at the TPSAC Meeting  

Center for Biologics Evaluation and Research (CBER)

... Dennis Henigan, Campaign for Tobacco-Free Kids (no slides); Bill Godshall, Smokefree Pennsylvania (no slides); Dr. David Abrams, Legacy. -. -. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/tobaccoproductsscientificadvisorycommittee

12

FDA Track and Trace Public Workshop - Day 1 Slides - CA ...  

Center for Drug Evaluation (CDER)

Text Version... If FDA enacts any rules or takes action inconsistent with any provision of CA law, that CA provision is inoperative ... CA Society of Health-System ... More results from www.fda.gov/downloads/drugs/newsevents

13

Presentation Slides for the January 30-31, 2012 Meeting of ...  

Center for Biologics Evaluation and Research (CBER)

Presentation Slides for the January 30-31, 2012 Meeting of the Pediatric Advisory Committee. Quick Links: Skip to main ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/pediatricadvisorycommittee

14

Presentation: McEvoy FDA Workshop  

Center for Drug Evaluation (CDER)

Text Version... background) – Use simple, familiar fonts with sufficient space within ... Optimize White Space – Use adequate white space between lines of text ... More results from www.fda.gov/downloads/drugs/newsevents

15

FDA Track and Trace Public Workshop - Day 2 Slides  

Center for Drug Evaluation (CDER)

Text Version... Creates a large amount of data that should be expertly managed and stored ... Session 3 – Data Management ... We want to understand the specific ... More results from www.fda.gov/downloads/drugs/newsevents

16

Slide Composition for Electronic Presentations  

ERIC Educational Resources Information Center

|Instructors who use computer-generated graphics in their lectures have many options to consider when developing their presentations. Experts give different advice on which typefaces, background and letter colors, and background imagery improve communications. This study attempted to resolve these controversies by examining how short-term recall…

Larson, Ronald B.

2004-01-01

17

Application of Information Retrieval Technologies to Presentation Slides  

Microsoft Academic Search

Presentations are becoming an increasingly more common means of communication in working environments, and slides are often the necessary supporting material on which the presentations rely. In this paper, we describe a slide indexing and retrieval system in which the slides are captured as images (through a framegrabber) at the moment they are displayed during a presentation and then transcribed

Alessandro Vinciarelli; Jean-marc Odobez

2006-01-01

18

FDA Small Business Regulatory Education for Industry (REdI) ...  

Center for Drug Evaluation (CDER)

... FDA Small Business Regulatory Education for Industry (REdI) Conference Spring 2013. For Slides from the Presentations ... More results from www.fda.gov/drugs/developmentapprovalprocess/smallbusinessassistance

19

2013 GDUFA and You Conference Presentation Slides  

Center for Drug Evaluation (CDER)

... Overview of GDUFA and Applications Under GDUFA (PDF - 1.1MB) Thomas Hinchliffe, Pharm.D., CDR, US Public Health Service Special Assistant ... More results from www.fda.gov/drugs/developmentapprovalprocess/smallbusinessassistance

20

FDA  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. Contains Nonbinding Recommendations Draft Guidance on Omeprazole, Sodium Bicarbonate and Magnesium Hydroxide ... More results from www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation

21

Alternative Films for Making Presentation Slides for the Occasional User.  

ERIC Educational Resources Information Center

As alternatives to the well-known Kodak Kodalith film for making presentation slides, suggests using Kodak Technical Pan Film, 2415 and Kodak Precision Fine Film LPD4. Although less known, both films are capable of making excellent quality slides with minimum effort and, for the occasional user, offer advantages over the Kodalith-Diazochrome…

Hunt, Harold R., Jr.

1985-01-01

22

Robust spatiotemporal matching of electronic slides to presentation videos.  

PubMed

We describe a robust and efficient method for automatically matching and time-aligning electronic slides to videos of corresponding presentations. Matching electronic slides to videos provides new methods for indexing, searching, and browsing videos in distance-learning applications. However, robust automatic matching is challenging due to varied frame composition, slide distortion, camera movement, low-quality video capture, and arbitrary slides sequence. Our fully automatic approach combines image-based matching of slide to video frames with a temporal model for slide changes and camera events. To address these challenges, we begin by extracting scale-invariant feature-transformation (SIFT) keypoints from both slides and video frames, and matching them subject to a consistent projective transformation (homography) by using random sample consensus (RANSAC). We use the initial set of matches to construct a background model and a binary classifier for separating video frames showing slides from those without. We then introduce a new matching scheme for exploiting less distinctive SIFT keypoints that enables us to tackle more difficult images. Finally, we improve upon the matching based on visual information by using estimated matching probabilities as part of a hidden Markov model (HMM) that integrates temporal information and detected camera operations. Detailed quantitative experiments characterize each part of our approach and demonstrate an average accuracy of over 95% in 13 presentation videos. PMID:21292597

Fan, Quanfu; Barnard, Kobus; Amir, Arnon; Efrat, Alon

2011-01-31

23

May 1, 2009: Slides from Scheduled or Committee ...  

Center for Biologics Evaluation and Research (CBER)

... May 1, 2009: Slides from Scheduled or Committee Presentations. -. Slides: Research Needs to Support Risk Communication. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/riskcommunicationadvisorycommittee

24

Slides for the September 16, 2009 Meeting of the Arthritis ...  

Center for Biologics Evaluation and Research (CBER)

... Slides for the September 16, 2009 Meeting of the Arthritis Drug Advisory Committee. FDA. Main Presentation (pdf). AUXILIUM. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

25

Presentation to: FDA, HHS: Radiological Devices Panel of the ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... DVD and IFU added more information on what to look for. - IFU improved with additional information (skin colour, lubricant use) ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

26

Presentation to the FDA Anti-Counterfeit Workshop February 8 ...  

Center for Drug Evaluation (CDER)

Text Version... “…the timing of flu vaccine shipments is crucial….” -New York Times “Phony Bird Flu Drugs Plaguing Internet” -Knight Ridder Newspapers ... More results from www.fda.gov/downloads/drugs/drugsafety

27

Environmental radiation standards. [Outline of slide presentation  

SciTech Connect

This document contains an outline of an oral presentation on environmental radiation standards presented to the American Nuclear Societies' Topical Conference on Population Exposure from the Nuclear Fuel Cycle. The paper contains several definitions, a summary of current radiation exposure limits; and numerous proposed changes to current standards. 7 figs. (TEM)

Kocher, D.C.

1987-01-01

28

FDA Presentation sNDA 21641(013):Rasagiline Delayed Start ...  

Center for Biologics Evaluation and Research (CBER)

Text Version1 FDA Presentation sNDA 21641(013):Rasagiline Delayed Start Trials in Parkinson's Disease Peripheral and Central Nervous System Drugs ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

29

Slides for the June 23, 2009 Meeting of the Pediatric Advisory ...  

Center for Biologics Evaluation and Research (CBER)

... Abbreviated Products: FDA Presentation Slides (PDF - 18KB); Overview of Secondary Exposure to Testosterone: Ellen Leschek, MD Presentation ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/pediatricadvisorycommittee

30

The Environmental Obligations of Experiential Education: A Slide Presentation [Script].  

ERIC Educational Resources Information Center

|The slide presentation script is intended to familiarize environmental educators with the "Whole Life Factor," an educational tool developed by the National Audubon Society Expedition Institute. The script first explores cultural images of nature and prejudice against nature. The theory that civilization perceives the planet as divided into…

Nadeau, Tina

31

13 0823 final slides FDA GPhA Meeting.pptx  

Center for Drug Evaluation (CDER)

Text Version... FY 2013 FY 2014 FY 2015 FY 2016 FY 2017 ANDA teleconference requests ... Meetings, Meetings and more Meetings 19 ... Meeting Requests ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

32

Slides for the June 21, 2010 Meeting of the Pediatric Advisory ...  

Center for Biologics Evaluation and Research (CBER)

... Zemuron: FDA Presentation Slides (PDF - 87KB); Overview on the Pediatric Device Consortia Grants Program: FDA Presentation (PDF - 241KB). -. -. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/pediatricadvisorycommittee

33

Slides presented by Nathan Dieckmann at the June 29, 2012 ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... There is agreement that fish losses are the result of habitat destruction and the building of dams to create reservoirs, used for irrigation by local ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

34

Slides for the December 8, 2009 Meeting of the Pediatric ...  

Center for Biologics Evaluation and Research (CBER)

... Update on Atypical Antipsychotics NICHD/NIH Working Group: NIH Presentation Slides (PDF - 69KB); Overview of November ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/pediatricadvisorycommittee

35

SLIDE PRESENTATION ON EMSP PROJECT 65328: ELECTRICALLY DRIVEN TECHNOLOGIES FOR RADIOACTIVE AEROSOL ABATEMENT  

EPA Science Inventory

These are the Powerpoint slides from a presentation on electrically driven technologies for radioactive aerosol abatement. The overall objectives of this project were:(1) to generate a scientific basis for developing innovative electrically based filtration systems that are appl...

36

Slide Presentations as Speech Suppressors: When and Why Learners Miss Oral Information  

ERIC Educational Resources Information Center

|The objective of this study was to test whether information presented on slides during presentations is retained at the expense of information presented only orally, and to investigate part of the conditions under which this effect occurs, and how it can be avoided. Such an effect could be expected and explained either as a kind of redundancy…

Wecker, Christof

2012-01-01

37

MAKE THEM SEE: DESIGNING EFFECTIVE PRESENTATION SLIDES (A PRELIMINARY VIEW)  

Microsoft Academic Search

We live in a visual age where images dominate the mass media. During the past century, written and oral modes of discourse have lost ground to visual ones. Presentation software, notably PowerPoint, is one more sign of the growing power of visual media to complement the printed word and the spoken word as well as compete with them. Unfortunately, visual

Laurence M. Dryden; Izumi Okuyama

38

Integrating Annotations into a Dual-Slide PowerPoint Presentation for Classroom Learning  

ERIC Educational Resources Information Center

|This study introduces a learning environment integrating annotations with a dual-slide PowerPoint presentation for classroom learning. Annotation means a kind of additional information to emphasize the explanations for the learning objects. The use of annotations is to support the cognitive process for PowerPoint presentation in a classroom. The…

Lai, Yen-Shou; Tsai, Hung-Hsu; Yu, Pao-Ta

2011-01-01

39

Tips for giving a memorable presentation, Part IV: Using and composing PowerPoint slides.  

PubMed

Visual aids such as PowerPoint slides can be helpful or deleterious to the quality of the talk, depending on how they are done and how they are used. This article will discuss ways to optimize the composition of PowerPoint presentations. This includes the appropriate composition of word slides and the use of the right font size and style of letters. It also includes tips in the use of color, special effects, and graphs. Pointers on how to properly anonymize patient images are also given. PMID:22899205

Harolds, Jay A

2012-10-01

40

A Need for Greater Transparency for Generic Drugs (Slides ...  

Center for Drug Evaluation (CDER)

Text Version... Transparency for Generic Drugs (Slides to accompany oral presentation) ... “Promote the public health” The Food and Drug Administration has ... More results from www.fda.gov/downloads/drugs/newsevents

41

Automatic Color Conversion Method for Color-Defective Vision about Presentation Slides  

NASA Astrophysics Data System (ADS)

This paper proposes the automatic color conversion method for color-defective vision persons about presentation slides. In order to set up this method, first, we defined the color combinations which are difficult to distinguish for color-defective vision persons by using the color confusion locus. Second, the function was derived which realizes the brightness difference values between strings and background. Then the automatic color conversion method was constructed by using above the color combinations and the function. By the experimental results, it turned out that the proposed method has been available for color-defective vision persons.

Yokota, Sho; Sasaki, Akinori; Hashimoto, Hiroshi; Ohyama, Yasuhiro

42

Communicating FDA's Safety Messages. Office of Special ...  

Center for Biologics Evaluation and Research (CBER)

... Slide 28. [Screen shot of MedWatch TNF-a Blockers Safety Alert]. Slide 29. Screen shot of TNF-a Blockers Safety Alert on IDSA web page]. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/riskcommunicationadvisorycommittee

43

FDA Centennial  

NSDL National Science Digital Library

On June 30th 1906, President Theodore Roosevelt signed the Food and Drugs Act, which prohibiting interstate commerce in misbranded and adulterated foods, drinks, and drugs. Broadly understood, this action was part of the Progressive Movement in the United States which brought forth a number of substantial changes in the way that government interacted with private industry and so on. 100 years on, the Food and Drug Administration (FDA) has decided to celebrate the centennial of this act by creating this site. Starting at the homepage, visitors can learn about events created to celebrate the FDA's legacy as well as read a nice feature titled "This Week in FDA History". Visitors may also want to look through a nice graphic presentation titled "FDA's Role in Protecting and Promoting Public Health". Through images and text, this presentation brings together some highlights of their work over the years, including information about the effects of the Federal Food, Drug, and Cosmetic Act of 1938. Finally, the site also contains a short quiz on FDA history.

2006-01-01

44

The effects of text slide format and presentational quality on learning in college lectures  

Microsoft Academic Search

The traditional advice for using text slides is to limit text on each slide to a maximum of about six or seven lines and a comparable number of words per line. But is the advice - never solidly based on research - really as good as it sounds? And does the way in which it is delivered - reading stiffly

Wim Blokzijl; B. Andeweg

2005-01-01

45

FROM LANTERN SLIDES TO IMAGE PRESENTATION SYSTEMS: A DISCIPLINE IN TRANSITION  

Microsoft Academic Search

ew corporate announcements have had the effect on entire academic disciplines that Eastman Kodak's 2003 decision to stop manufacturing slide projectors had on Art History. The known world of side- by-side slide projection, large luminous images, well- organized institutional collections, last-minute lecture preparation, excellent commercial suppliers, and easy in-house production to support even the most special- ized of topics seemed

Eileen Fry

46

Food Safety for Moms-to-Be: Educator Tools - Slides/Talking ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... Food Safety for Moms-to-Be: Educator Tools - Slides/Talking Points - Powerpoint Presentation Table of Contents. Food ... More results from www.fda.gov/food/foodborneillnesscontaminants/peopleatrisk

47

Teacher Education Students' Perceptions of the Value of Handouts Accompanying Teacher Educators' Computer-Generated Slide Presentations  

ERIC Educational Resources Information Center

This mixed-methods study used interviews and a questionnaire to investigate the perceptions of 304 teacher education students regarding the learning-related value of handouts accompanying teacher educators' computer-generated slide presentations. The extent to which graduate and undergraduate students differed in their perceptions was also…

Yilmazel-Sahin, Yesim; Oxford, Rebecca L.

2010-01-01

48

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... FDA Presentations 10:40 am Overview of Clinical Program Sofia Chaudhry, MD Clinical Reviewer, DPARP, ODE-II, OND, CDER, FDA ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

49

Slides for the May 6-7, 2010 Meeting  

Center for Biologics Evaluation and Research (CBER)

... and Drug Administration. -. Slides for the May 6-7, 2010 Meeting. -. Slides: May 6, 2010; Slides: May 7, 2010. -. -. -. Page Last Updated ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/riskcommunicationadvisorycommittee

50

Historical overview of FDA regulation of digital pathology ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Whole slide imaging (WSI), aka digital imaging, virtual slides, virtual microscopy; ... technological advances associated with WSI make its use a reality; ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

51

FDA Perspective  

Center for Biologics Evaluation and Research (CBER)

Text Version... Blood Safety Team (BST) reviewed rising numbers of reports; BST requested additional information from several manufacturers; ... More results from www.fda.gov/downloads/biologicsbloodvaccines/newsevents

52

Electric Slide  

NSDL National Science Digital Library

To some the electric slide may just be a novelty dance. Astute readers of technology blogs will know that this Electric Slide happens to be a application that allows visitors to wirelessly present their PowerPoint slides, documents, and videos using just their iPhone or iPad. First-time visitors can watch an instructional video and then go ahead and get started. The Features area contains details on the operations of the program and the Help section offers up some useful suggestions. This version is compatible with all operating systems running iOS 5.1.1 and newer.

2013-07-11

53

FDA Almanac  

NSDL National Science Digital Library

The Office of Public Affairs for the Food and Drug Administration, the Public Health Service, and the Department of Health & Human Services has placed the most recent FDA Almanac online. The Almanac serves as a comprehensive starting point for information on the FDA and its subsidiary agencies. The introduction offers an overview of the FDA's organization, its mission, and its vision for the year 2000, as well as a compilation of the major laws it enforces. The Almanac itself contains information on the agency's 1999 budget and links to its major departments, such as the Center for Drug Evaluation and Research, the Center for Food Safety and Applied Nutrition, and the Office of Regulatory Affairs. Additional resources include a list of milestones in US food and drug law history, FDA-related acronyms and abbreviations, and a guide to obtaining information from the FDA.

Administration., United S.

1999-01-01

54

FDA Review  

Center for Biologics Evaluation and Research (CBER)

Text Version... 6 Breast Density/Composition BI-RADS ® Categories Breast Density/ Composition BI-RADS ® Categories BI-RADS 1 fatty breast ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

55

FDA Transcript  

Center for Biologics Evaluation and Research (CBER)

Text Version... Page 26. 26 oxides, such as paramagnetic iron oxide, titanium dioxide, zinc oxide, and then silver and gold nanoparticles. But this is not everything. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

56

FDA Webinar  

Center for Drug Evaluation (CDER)

Text Version... In the Search Documents box, type: 2009-N-0143 – Press: Go ... 6 Questions to Consider Federal Register 74:74 (April 20, 2009) p. 17967-17970 ... More results from www.fda.gov/downloads/drugs/drugsafety

57

FDA Transcript  

Center for Biologics Evaluation and Research (CBER)

Text Version... rapid fluctuations in blood pressure. On the left you can see a brain SPECT ... The supine brain image on the right demonstrates a ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

58

FDA Transcript  

Center for Biologics Evaluation and Research (CBER)

Text Version... 20 21 22 Finally, we will conclude with Dr. Bateman looking at the risk/benefit issues, and also ... benefits, transitory benefits, or are poorly tolerated. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

59

FDA Transcript  

Center for Biologics Evaluation and Research (CBER)

Text Version... business tobacco manufacturing industry, and tobacco growers, respectively. Their role at this meeting is to represent these industries in general ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

60

FDA Transcript  

Center for Biologics Evaluation and Research (CBER)

Text Version... So the mechanistic PBPK model ... have been developed for animal models, animals and humans. ... was in 2001, and this written request was modeled ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

61

FDA Review  

Center for Biologics Evaluation and Research (CBER)

Text Version... events, gastrointestinal perforation, bleeding events, hypothyroidism, proteinuria, ... Hypothyroidism 0 50 (14.1) 0 114 (31.6) Dysphonia ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

62

FDA Webinar  

Center for Drug Evaluation (CDER)

Text Version... B. REMS Elements C. Possible REMS Elements for Opioid Analgesics ... New safety information is defined as a serious risk associated ... More results from www.fda.gov/downloads/drugs/drugsafety

63

FDA Transcript  

Center for Biologics Evaluation and Research (CBER)

Text Version... speed, 50 or 100 RPMS. Occasionally, if you have a ... literature publications, there is one from 1961. ... performance in different pH media. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

64

FDA Transcript  

Center for Biologics Evaluation and Research (CBER)

Text Version... CRADAs, teaching, speaking, writing, patents and ... The right-hand side then shows selectivity ... for either first-line or second-line therapy in ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

65

FDA Webinar  

Center for Drug Evaluation (CDER)

Text Version... and Input Douglas C. Throckmorton, MD Deputy Director ... and Input • We must find a way to work together to achieve our goals: ... More results from www.fda.gov/downloads/drugs/drugsafety

66

FDA Transcript  

Center for Biologics Evaluation and Research (CBER)

Text Version... behalf of regulated industry. His role at this ... lengths. As you can see, in the group of women ... in a short cervix provides an opportunity for ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

67

FDA Standardization  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... for immediate service and comminuted meat on a ... meats or mechanically tenderized meats cooked to 68°C ... Total Inspection Time: Date: Location of ... More results from www.fda.gov/downloads/food/guidanceregulation

68

FDA Transcript  

Center for Biologics Evaluation and Research (CBER)

Text Version... So all further tests, all further tests on 5 milligrams stop at this point; 2.5 milligrams has ... At one to two days after stopping ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

69

Slides for the February 24, 2009 Meeting of the Science Board ...  

Center for Biologics Evaluation and Research (CBER)

... Rapid Detection of Contaminants in Food Slides (PDF - 155KB) [ARCHIVED]; Economically Motivated Adulteration of FDA Regulated Products ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/scienceboardtothefoodanddrugadministration

70

FDA Transcript ODAC  

Center for Biologics Evaluation and Research (CBER)

Text Version... 13 Sponsor Presentation – Onyx Pharmaceuticals, Inc. Introduction Ted Love, MD 18 ... Sponsor Presentation - Ted Love DR. LOVE: Good afternoon. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

71

Educational Slides: Form and Function.  

National Technical Information Service (NTIS)

Designed for use by teachers, librarians, and media specialists, the slide/tape program described presents an introduction to the production and uses of educational slides in the classroom with emphasis on the relative ease of producing and using slides, ...

M. A. Bor

1977-01-01

72

FDA Executive Summary Memorandum  

Center for Biologics Evaluation and Research (CBER)

Text Version... Miliary brain metastases presenting as rapidly progressive dementia. ... Cumulative revision rate (CRR) ~Sex, age differences ... Male: 61 Female: 119 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

73

Transcript - FDA TPSAC  

Center for Biologics Evaluation and Research (CBER)

Text Version... that we're presenting now, is to inform decisions ... Our first aim is informed by the formative research that was ... Within each product type, we had a ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

74

Reach Out and Teach: Library Instruction in Mississippi Libraries. Script for Slide Presentation.  

ERIC Educational Resources Information Center

|This script was prepared as part of a program presented by the Library Instruction Roundtable (LIRT) to share ways libraries in Mississippi help patrons use library resources. The program evolved from a 1981 needs assessment survey conducted by the Mississippi Library Association (MLA) Education Committee. At that time requests for information…

Ellsbury, Susan H.; Rafferty, Randy

75

Reach Out and Teach: Library Instruction in Mississippi Libraries. Script for Slide Presentation.  

ERIC Educational Resources Information Center

This script was prepared as part of a program presented by the Library Instruction Roundtable (LIRT) to share ways libraries in Mississippi help patrons use library resources. The program evolved from a 1981 needs assessment survey conducted by the Mississippi Library Association (MLA) Education Committee. At that time requests for information and…

Ellsbury, Susan H.; Rafferty, Randy

76

FDA Transcript  

Center for Biologics Evaluation and Research (CBER)

Text Version... interesting idea. So of course, we're constrained by the fact that this is a longitudinal survey, and ... Street. And Judy gave you a lot of facts, so four ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

77

FDA AADPAC  

Center for Biologics Evaluation and Research (CBER)

Text Version... 60-minute applications. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 ... conditions. While smoked cannabis and NGF have ... healthy volunteers in earlier studies. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

78

FDA Transcript  

Center for Biologics Evaluation and Research (CBER)

Text Version... that to also ask, and does it have to be the same one? ... And I was convinced it did. And they are ... been alluded to by several people has to do with ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

79

FDA Review  

Center for Biologics Evaluation and Research (CBER)

Text Version... Accelerated/Blast phases: • Complete hematologic response ... 6.6 5.1 Min, Max 0.9, 14.8 0.9, 14.8 ... Phase • Adjudicated complete hematologic ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

80

FDA Actions to Date  

Center for Food Safety and Applied Nutrition (CFSAN)

... FDA, US Food and Drug Administration. US Food & Drug Administration. A to Z Index; Follow FDA; FDA Voice Blog. ... FDA Actions to Date. ... More results from www.fda.gov/food/guidanceregulation/fsma

81

November 13, 2009: Presentations  

Center for Biologics Evaluation and Research (CBER)

... Slides: Tobacco and Health Promotion: Some Observations William D. Novelli (PDF - 47KB). -. -. -. Page Last Updated: 09 ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/riskcommunicationadvisorycommittee

82

Educator Tools - Slides/Talking Points - Review & Wrap Up ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... Section Contents Menu. Resources for You. ... Educator Tools - Slides/Talking Points - Review & Wrap Up Opening Slide. Return to Table of Contents. ... More results from www.fda.gov/food/resourcesforyou/healtheducators

83

May 1, 2009: Slides from Open Public Hearing  

Center for Biologics Evaluation and Research (CBER)

... May 1, 2009: Slides from Open Public Hearing. -. Slides: Concentrics Research, LLC. Julie L. Aker (PDF - 146KB). -. -. -. Page ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/riskcommunicationadvisorycommittee

84

Slides for the November 30, 2010 Meeting of the Pediatric ...  

Center for Biologics Evaluation and Research (CBER)

... Slides for the November 30, 2010 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

85

Slides for the March 2, 2011 Meeting of the Pharmaceutical ...  

Center for Biologics Evaluation and Research (CBER)

... Slides for the March 2, 2011 Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. Persons ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

86

Slides for the September 13, 2012 Meeting of the ...  

Center for Biologics Evaluation and Research (CBER)

... West-Ward Pharmaceutical Corp. West-Ward Slides, Phenylephrine Hydrochloride Injection, for the September 13, 2012 ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

87

Slides from the October 7 Meeting of the Tobacco Products ...  

Center for Biologics Evaluation and Research (CBER)

... Slides from the October 7 Meeting of the Tobacco Products Scientific Advisory Committee. DISCLAIMER ... committee. October 7, 2010. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/tobaccoproductsscientificadvisorycommittee

88

FDA Drug Safety Newsletter  

Center for Drug Evaluation (CDER)

... Section Contents Menu. Drug Safety and Availability. FDA Drug Safety Newsletter. ... FDA Drug Safety Newsletter. The FDA Drug Safety ... More results from www.fda.gov/drugs/drugsafety/drugsafetynewsletter

89

Adverse Event Report for an Immune Globulin: FDA ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... SLIDE 3 A serious adverse event is an event that has been associated with death, a life- threatening event, a hospital admission or prolongation of ... More results from www.fda.gov/downloads/biologicsbloodvaccines/internationalactivities

90

Digital Whole Slide Imaging for Patient Care  

Center for Biologics Evaluation and Research (CBER)

Text Version... The Robotic System: November 2004-October 2006. 350 frozen sections; accurate; deferral rate < 10%. slow (~ 10 minutes/slide). ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

91

FDA Drug Safety Communication: FDA approves label ...  

Center for Drug Evaluation (CDER)

... literature case series, 3-4 information from FDA's Mini-Sentinel pilot of the Sentinel Initiative, and information from the CMS Medicare database. ... More results from www.fda.gov/drugs/drugsafety

92

FDA Drug Safety Communication: FDA alerts healthcare ...  

Center for Drug Evaluation (CDER)

... FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients. ... More results from www.fda.gov/drugs/drugsafety

93

Genotyping of Mycobacterium leprae present on Ziehl-Neelsen-stained microscopic slides and in skin biopsy samples from leprosy patients in different geographic regions of Brazil.  

PubMed

We analysed 16 variable number tandem repeats (VNTR) and three single-nucleotide polymorphisms (SNP) in Mycobacterium leprae present on 115 Ziehl-Neelsen (Z-N)-stained slides and in 51 skin biopsy samples derived from leprosy patients from Ceará (n = 23), Pernambuco (n = 41), Rio de Janeiro (n = 22) and Rondônia (RO) (n = 78). All skin biopsies yielded SNP-based genotypes, while 48 of the samples (94.1%) yielded complete VNTR genotypes. We evaluated two procedures for extracting M. leprae DNA from Z-N-stained slides: the first including Chelex and the other combining proteinase and sodium dodecyl sulfate. Of the 76 samples processed using the first procedure, 30.2% were positive for 16 or 15 VNTRs, whereas of the 39 samples processed using the second procedure, 28.2% yielded genotypes defined by at least 10 VNTRs. Combined VNTR and SNP analysis revealed large variability in genotypes, but a high prevalence of SNP genotype 4 in the Northeast Region of Brazil. Our observation of two samples from RO with an identical genotype and seven groups with similar genotypes, including four derived from residents of the same state or region, suggest a tendency to form groups according to the origin of the isolates. This study demonstrates the existence of geographically related M. leprae genotypes and that Z-N-stained slides are an alternative source for M. leprae genotyping. PMID:23283465

Fontes, Amanda Nogueira Brum; Gomes, Harrison Magdinier; de Araujo, Marcelo Ivens; de Albuquerque, Edson Cláudio Araripe; Baptista, Ida Maria Foschiani Dias; Moura, Maria Manuela da Fonseca; Rezende, Denise Silva; Pessolani, Maria Cristina Vidal; Lara, Flávio Alves; Pontes, Maria Araci de Andrade; Gonçalves, Heitor de Sá; Lucena-Silva, Norma; Sarno, Euzenir Nunes; Vissa, Varalakshmi D; Brennan, Patrick J; Suffys, Philip Noel

2012-12-01

94

FDA Hot Topics  

Center for Biologics Evaluation and Research (CBER)

Text VersionFDA Hot Topics. Alan E. Williams, Ph.D. ... January 27-29, 2010. FDA Hot topics. The Office of Blood Research and Review (OBRR), CBER. ... More results from www.fda.gov/downloads/biologicsbloodvaccines/newsevents

95

FDA Drug Safety Podcasts  

Center for Drug Evaluation (CDER)

... FDA Drug Safety Podcast: FDA requiring color changes to Duragesic (fentanyl) pain ... due to risk of serious psychiatric and nerve side effects, July 29 ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

96

FDA 101: Dietary Supplements  

MedlinePLUS

... to Z Index Follow FDA FDA Voice Blog Enter Search terms Search the FDA Archive Home Food Drugs Medical ... is no longer maintained and may be outdated. Enter Search terms For Consumers Home For Consumers Consumer Updates Section ...

97

FDA PSYCHOPHARMACOLOGIC DRUGS ADVISORY ...  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. 1 FDA PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE MEETING VIVITROL ® (naltrexone for extended ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

98

Title Slide  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. 1 ECMO should be Class III for Adult Cardiac Failure • Abiomed supports FDA position that ECMO should remain as Class III for ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

99

A Novel Fiber-Optic Slide-Sensing Scheme  

Microsoft Academic Search

A novel fiber-optic slide sensor is presented in this paper. The slide sensor is designed for robust hands or intelligent mechanical clamping apparatuses. In the slide sensor designing, a slide ball has been used as a slide transfer device of the sensor. In the center of the inside-sliding ball, a plane reflective mirror has been fixed with the ball to

Libo Yuan

2001-01-01

100

FDA Gastrointestinal Drugs Advisory Committee  

Center for Biologics Evaluation and Research (CBER)

Text Version... REMICADE® - Pediatric Ulcerative Colitis Stella S. Jones, PhD Vice President, Global Regulatory Affairs ... Presentation Agenda Stella S. Jones, PhD ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

101

Science Board to the FDA  

Center for Biologics Evaluation and Research (CBER)

Text Version... Recipients' Presentation The Finasteride and Dutasteride Review Team (OHOP/OND/CDER) ... Finasteride (NDA 020180/s034): Submitted at the ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

102

Slides for the July 15, 2009 Meeting of the Oncologic Drug ...  

Center for Biologics Evaluation and Research (CBER)

... Sponsor (pdf) Backup Slides (pdf). Centocor Ortho Biotech Products, LP. ... Sponsor (pdf) Backup Slides (pdf). Centocor Ortho Biotech Products, LP. -. -. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

103

Paleoclimatology Slides  

NSDL National Science Digital Library

These slide sets have been produced by the National Oceanic and Atmospheric Administration (NOAA) to illustrate some of the concepts and methods involved in paleoclimate research. Each set of 20-40 slides includes vivid photographs of field research conducted around the globe, high-quality graphics of important datasets, and descriptive diagrams, making these sets ideal instructional aides. The slide sets can be purchased as 35 mm slides or viewed online. The online version includes a glossary, detailed background information and large, high-resolution versions of each slide. Included is a detailed narrative that is designed to accompany the slides. Topics include the ice ages, climate and the classic Maya civilization, coral paleoclimatology, polar ice cores, pack rat middens, tree rings, Heinrich events, and low latitude ice cores.

2001-10-12

104

Drugs@FDA: FDA Approved Drug Products  

MedlinePLUS

... to Z Index Follow FDA FDA Voice Blog Enter Search terms Most Popular Searches Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & ... Search by Drug Name, Active Ingredient, or Application Number Enter at least three characters: Advanced Search Browse by ...

105

Slides for the January 6, 2012 Meeting of the Science Board to ...  

Center for Biologics Evaluation and Research (CBER)

... Slides for the January 6, 2012 Meeting of the Science Board to the FDA. Persons with disabilities having problems accessing ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/scienceboardtothefoodanddrugadministration

106

Slides for the April 2, 2009 Meeting of the Endocrinologic and ...  

Center for Biologics Evaluation and Research (CBER)

... FDA. Master Slide/Table of Contents [PDF]. Hylton Joffe, MD, MMSc., Diabetes Clinical Team Leader, CDER, DMEP [PDF]. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

107

Slides for the October 3, 2012 Meeting of the Science Board to ...  

Center for Biologics Evaluation and Research (CBER)

... Slides for the October 3, 2012 Meeting of the Science Board to the FDA. Persons with disabilities having problems accessing ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/scienceboardtothefoodanddrugadministration

108

Slide system for machine tools  

DOEpatents

The present invention relates to a machine tool which permits the machining of nonaxisymmetric surfaces on a workpiece while rotating the workpiece about a central axis of rotation. The machine tool comprises a conventional two-slide system (X-Y) with one of these slides being provided with a relatively short travel high-speed auxiliary slide which carries the material-removing tool. The auxiliary slide is synchronized with the spindle speed and the position of the other two slides and provides a high-speed reciprocating motion required for the displacement of the cutting tool for generating a nonaxisymmetric surface at a selected location on the workpiece.

Douglass, S.S.; Green, W.L.

1980-06-12

109

Slide system for machine tools  

DOEpatents

The present invention relates to a machine tool which permits the machining of nonaxisymmetric surfaces on a workpiece while rotating the workpiece about a central axis of rotation. The machine tool comprises a conventional two-slide system (X-Y) with one of these slides being provided with a relatively short travel high-speed auxiliary slide which carries the material-removing tool. The auxiliary slide is synchronized with the spindle speed and the position of the other two slides and provides a high-speed reciprocating motion required for the displacement of the cutting tool for generating a nonaxisymmetric surface at a selected location on the workpiece.

Douglass, Spivey S. (Oak Ridge, TN); Green, Walter L. (Knoxville, TN)

1982-01-01

110

Presentations  

Center for Drug Evaluation (CDER)

... Print; Share; E-mail. Home; Drugs; News & ... Chellappan, Ph.D., H. Lee Moffitt Cancer ... Vermont (PDF - 845KB) [ARCHIVED]; Robert Murray, Vancouver ... More results from www.fda.gov/drugs/newsevents

111

FDA's New Prescribing Information:  

Center for Drug Evaluation (CDER)

Text Version... For example, the recently launched DailyMed, a health information clearinghouse created by FDA and the National Library of Medicine, has begun ... More results from www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation

112

ASCO/FDA JOINT  

Center for Drug Evaluation (CDER)

Text VersionPage 1. ASCO/FDA JOINT LUNG CANCER PANEL 2002-2003 Paul Bunn, MD (NCE-Chair) University of Colorado Cancer Center Denver, CO ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

113

DRAFT FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ PublicHealthNotifications/ucm241809.htm . 5 Polish L, Shapiro C, Bauer F ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

114

FDA AAC Meeting  

Center for Biologics Evaluation and Research (CBER)

Text Version... DR. HERTZ: Sharon Hertz, FDA, same division. ... administer to and study their drugs in human subjects. Partial clinical hold means that the drug ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

115

FDA Oysters bro.  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... Carlos feels worse and the nurse calls a ... Make sure to tell the nurses and doctors on ... further information contact: FDA Food Safety Hotline (English ... More results from www.fda.gov/downloads/food/foodborneillnesscontaminants

116

FDA Public Workshop  

Center for Drug Evaluation (CDER)

Text VersionPage 1. FDA Public Workshop Clinical Development Programs for Sedation Productions Speaker, Panelist and Moderator Disclosure Form ... More results from www.fda.gov/downloads/drugs/newsevents

117

FDA Food Code  

Center for Food Safety and Applied Nutrition (CFSAN)

The Food Code represents FDA's best advice for a system of provisions that address the safety and protection of food offered at retail and in food ... More results from www.fda.gov/food/guidanceregulation/retailfoodprotection

118

FDA Assistance to Industry  

Center for Drug Evaluation (CDER)

Text Version... Page 5. FDA Jurisdiction • Foods • Drugs • Biologics • Cosmetics • Medical devices • Veterinary products • Radiation-emitting products Page 6. ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

119

FDA-iRISK  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... sheet gives an overview of the FDA-iRISK model structure; ie, inputs ... in equations to perform Monte Carlo simulations in pre-structured models, to ... More results from www.fda.gov/downloads/food/foodscienceresearch

120

DRAFT FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... These areas of consideration, along with questions to the panel, are discussed in detail in Section 6.3 of this FDA Executive Summary ... Page 12 of 51 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

121

FDA Briefing Document  

Center for Biologics Evaluation and Research (CBER)

Text Version... 11 Table 5: Study HBS407 - Prior Anti-leukemic Agents.....12 Table 6: FDA Review of CR+CRi Rates Based on Review ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

122

FDA Drug Info Rounds  

Center for Drug Evaluation (CDER)

... and Risk Information (August 2013) FDA Drug Info Rounds pharmacists talk about the benefit risk balance, and how health care professionals may ... More results from www.fda.gov/drugs/resourcesforyou/healthprofessionals

123

Pharmacy Compounding: FDA Actions  

Center for Drug Evaluation (CDER)

... 2011. Drug Safety Alert: FDA Alerts Health Care Professionals of Infection Risk from Repackaged Avastin Intravitreal Injections (08/30/2011). 2010. ... More results from www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding

124

FDA Drug Safety Communication: FDA approves label ...  

Center for Drug Evaluation (CDER)

Text Version... Also indicated for the prevention of malaria infections by P. falciparum (including chloroquine- resistant P. falciparum) and P. vivax. Page 2. ... More results from www.fda.gov/downloads/drugs/drugsafety

125

FDA Drug Safety Communication: FDA Recommends Against ...  

Center for Drug Evaluation (CDER)

... the pregnant woman develops high blood pressure and protein in the ... only by trained obstetrical personnel in a hospital setting with appropriate ... More results from www.fda.gov/drugs/drugsafety

126

FDA Drug Safety Communication: FDA requiring color ...  

Center for Drug Evaluation (CDER)

... dangerous and even cause death, in babies, children, adults ... pouch; (2) remove its protective liner; (3) fold the ... transfer of a patch from a parent to a ... More results from www.fda.gov/drugs/drugsafety

127

FDA Drug Safety Communication: FDA approves label ...  

Center for Drug Evaluation (CDER)

... The disease is a problem primarily in developing ... Confusion; Behavior that is unusual. Carefully read the ... no known major medical problems prior to ... More results from www.fda.gov/drugs/drugsafety

128

FDA Transcript: FDA Chronic Pain Workshop  

Center for Drug Evaluation (CDER)

Text Version... applications and licenses, for technology innovations in pain management. He's also received ... scientific fashion. Firstly, my disclosures. ... More results from www.fda.gov/downloads/drugs/newsevents

129

FDA Drug Safety Communication: FDA investigating leukemia ...  

Center for Drug Evaluation (CDER)

... such as chest pain or pressure, pain in their arms, back, neck or jaw ... artery disease, stroke, narrowing of large arteries of the brain, severe narrowing ... More results from www.fda.gov/drugs/drugsafety

130

FDA Drug Safety Communication: FDA recommends against ...  

Center for Drug Evaluation (CDER)

... outlined in the Federal Drug Disposal Guidelines: ... 12) against the continued marketing of propoxyphene ... to remain on the market advised requiring ... More results from www.fda.gov/drugs/drugsafety

131

FDA Patient Representatives and FDA Consumer ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Regional or local organizations • Health care providers • Self-nominations • Web searches • Other sources • Importance of conflicts of interest ... More results from www.fda.gov/downloads/advisorycommittees/aboutadvisorycommittees

132

Educator Tools - Slides/Talking Points - True or False Answer ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... Educator Tools - Slides/Talking Points - True or False Answer #2. Return to Table of Contents. ... True or False? Foodborne illness doesn't affect me. ... More results from www.fda.gov/food/resourcesforyou/healtheducators

133

Slides for the August 13-14, 2009 Meeting  

Center for Biologics Evaluation and Research (CBER)

... Roster of the Risk Communication Advisory Committee to the Food and Drug Administration. -. Slides for the August 13-14, 2009 Meeting. -. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/riskcommunicationadvisorycommittee

134

Slides for the December 4, 2012 Meeting of the Pediatric ...  

Center for Biologics Evaluation and Research (CBER)

... Slides for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PedsODAC). ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

135

Slides for the September 25, 2013 Meeting of the Advisory ...  

Center for Biologics Evaluation and Research (CBER)

... Slides for the September 25, 2013 Meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (ACPS-CP). ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

136

February 27, 2009: Slides from Scheduled or Committee ...  

Center for Biologics Evaluation and Research (CBER)

... DK Theo Raynor (PDF - 1.3MB); Slides: Communicating with patients about prescription drugs and health care: The role of diminished status and ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/riskcommunicationadvisorycommittee

137

A novel adaptive sliding mode controller for MEMS gyroscope  

Microsoft Academic Search

This paper presents a new adaptive sliding mode controller for MEMS gyroscope; an adaptive tracking controller with a proportional and integral sliding surface is proposed. The adaptive sliding mode control algorithm can estimate the angular velocity vector and the linear damping and stiffness coefficients in real time. A proportional and integral sliding surface, instead of a conventional sliding surface is

J. Fei; C. Batur

2007-01-01

138

A class of adaptive sliding mode controller with integral sliding surface  

Microsoft Academic Search

This paper presents an adaptive sliding mode tracking controller with a proportional and integral switching surface. A novel adaptive sliding mode controller based on model reference adaptive state feedback control is proposed to deal with the tracking problem for a class of dynamic systems. First, a proportional and integral sliding surface instead of a conventional sliding surface is chosen and

Juntao Fei

2009-01-01

139

Slide Master  

Center for Biologics Evaluation and Research (CBER)

Text Version... supporting? b. Based on the available scientific evidence and proposed ... following cardiac surgery) in all pediatric patients? ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

140

ACPS Slides  

Center for Biologics Evaluation and Research (CBER)

Text Version... Reduced QC Lab costs ... Crystallization Feed) 9 5 1 45 Higher water = higher degradation In process control assay should ensure detection and ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

141

PPT Slide  

Center for Drug Evaluation (CDER)

... concentrations at specific time points, up to 24 hours, following administration of a single dose of felodipine with 250 cc of grapefruit juice or water. ... More results from www.fda.gov/drugs/developmentapprovalprocess/developmentresources

142

Slide Master  

Center for Biologics Evaluation and Research (CBER)

Text Version... Case-control study (Casner ... an adequate assurance of safety and effectiveness for CPR ... the application of and quality of CPR being delivered to the ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

143

ODAC Slides  

Center for Biologics Evaluation and Research (CBER)

Text Version... Based on Literature Review Agent (year reported) Number treated Prior ... Alkylating Agents* ?2 (100%), ?3 (99%), ?4 (94%), ?5 (66%) ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

144

Slide Master  

Center for Biologics Evaluation and Research (CBER)

Text Version... unintentional dose is delivered in the Gammacell 220. ... Dosimetry variation was measured when delivered in a Gammacell 3000 (with ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

145

AC Slides  

Center for Biologics Evaluation and Research (CBER)

Text Version... Page 12. 12 Management of INR in ROCKET • Protocol specified a procedure for starting ... 5 1.0% 0.0% ROCKET – Percent Time in Various ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

146

Enforcement Activities by FDA  

Center for Drug Evaluation (CDER)

... Fake Cancer Cures; Regulatory Action Against Ranbaxy. -. ? -. Related Link. Clinical Investigator Inspection List (CIIL) Database Codes. -. -. -. ... More results from www.fda.gov/drugs/guidancecomplianceregulatoryinformation/enforcementactivitiesbyfda

147

FDA-Defined Valvulopathy  

Center for Biologics Evaluation and Research (CBER)

Text Version... Pitavastatin – Lovastatin – Pravastatin • Combination Statins ... Vytorin (ezetimibe- simvastatin) – Advicor (niacin-lovastatin) – Simcor (niacin- ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

148

Slide Whistle  

NSDL National Science Digital Library

In this activity, learners build a slide whistle using PVC pipe, bamboo skewer, and piece of foam. Construction of the instrument is relatively simple. Learners will experiment making sounds and varying the pitch (frequency). Use this activity to help learners explore sound, instruments, vibration, and frequency. Adult supervision recommended.

Workshop, Watsonville E.

2011-01-01

149

Slides from the July 21-22, 2011 TPSAC Meeting ...  

Center for Biologics Evaluation and Research (CBER)

... FDA presentation: Dissolvable Tobacco Products. ... Vice President, Smokeless Product Development, RJ ... presentations: Abuse Liability and Health ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/tobaccoproductsscientificadvisorycommittee

150

FDA's Drug Review Process: Continued  

Center for Drug Evaluation (CDER)

... FDA has 60 days to decide whether to file it so ... If the FDA files the NDA, an FDA review team is ... Once a new drug application is filed, an FDA review ... More results from www.fda.gov/drugs/resourcesforyou/consumers

151

FDA Drug Safety Podcast: FDA approves label changes to ...  

Center for Drug Evaluation (CDER)

... FDA Drug Safety Podcast: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

152

FDA Drug Safety Podcast: FDA significantly restricts access to ...  

Center for Drug Evaluation (CDER)

... FDA Drug Safety Podcast: FDA significantly restricts access to the diabetes drug Avandia. Listen to this Podcast. On September ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

153

FDA Posts 2002 FDA Health and Diet Survey Topline ...  

Center for Food Safety and Applied Nutrition (CFSAN)

2002 FDA Health and Diet Survey Topline Frequency Report: The survey fills an important FDA informational need in protecting and promoting the ... More results from www.fda.gov/food/newsevents/constituentupdates

154

FDA Drug Safety Podcast: FDA approves new label changes ...  

Center for Drug Evaluation (CDER)

... FDA Drug Safety Podcast: FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day after ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

155

Fiber optic sliding sensor model and its simulation  

Microsoft Academic Search

A theoretical analysis model of fiber-optic sliding sensor is presented. The sliding sensor is designed for robot hands or intelligent mechanical clamping apparatuses. In the sliding sensor designing, a sliding ball has been used as sliding transfer device of the sensor. In the center of the in side sliding ball, a 4-face-prismoid reflective mirror has been fixed with the ball

Libo Yuan; Yijun Liang; Xiaoyan Lin; Yande Xu; Shunling Ruan

1998-01-01

156

Slide 1  

Cancer.gov

Phase 0 trials can start earlier than Phase 1 Conceived under FDA’s “Critical Path” initiative to help sponsors identify promising candidate drugs more quickly Toxicology evaluation less extensive than for traditional IND because of reduced dosing and limited exposure.

157

Backup Slides  

Center for Biologics Evaluation and Research (CBER)

Text Version... 5. Capel et al, 2003 6. Clark et al, 1989 7. Shill et al, 2011 8. Smith et al, 1975 9. Weingarten et al, 1981 10. Pickworth et al, 1997 Page 36. 36 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

158

Selected Publications & Presentations  

Center for Food Safety and Applied Nutrition (CFSAN)

... Selected Publications & Presentations. Recent Food Research Publications and FDA Publications Database. 2008 Intramural Research Portfolio. ... More results from www.fda.gov/food/foodscienceresearch/toolsmaterials

159

June 29, 2012: Meeting Presentations-Outline Form  

Center for Biologics Evaluation and Research (CBER)

... FDA Update 06/29/12 - Slides Outline (PDF - 128KB); Peters - Introduction and Overview - Recent Research on Communicating Uncertainty 06/29 ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/riskcommunicationadvisorycommittee

160

Generic FDA Statement  

Center for Drug Evaluation (CDER)

Text Version... Page 2. Statement of William Vaughan, Health Policy Analyst Consumers Union, the independent, non-profit publisher of Consumer Reports 1 ... More results from www.fda.gov/downloads/drugs/newsevents

161

FORM FDA 3613b  

Center for Drug Evaluation (CDER)

Text Version... issued. Country of Destination Certificate requests, for multiple countries, can be made in one ap- plication. A certificate ... More results from www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation

162

FDA Executive Summary Memorandum  

Center for Biologics Evaluation and Research (CBER)

Text Version... revision surgery. 1 Machado C, Appelbe A, Wood R. Arthroprosthetic Cobaltism and Cardiomyopathy. Heart Lung Circ. Apr ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

163

FDA Patient Advisory  

Center for Biologics Evaluation and Research (CBER)

Text Version... di i It is very important for diabetics to test their blood sugar so that they can keep ... check the drugs they use that contain the above sugars. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

164

Communicating FDA's Safety Messages  

Center for Biologics Evaluation and Research (CBER)

Text Version... 20 Promotion of Consumer MedWatch Form ... Librarians – Health professional organizations ... groups • Electronic newsletters, e-lists, Twitter ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

165

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... 11. Boudjemline Y, Brugada G, Van-Aerschot I, Patel M, Basquin A, Bonnet C, Legendre A, Bonnet D, Iserin L. Outcomes and safety of transcatheter ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

166

FDA Draft Questions  

Center for Biologics Evaluation and Research (CBER)

Text Version... the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease (DDD), and spondylolisthesis other than ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

167

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... blockers, and proton pump inhibitors (PPIs). ... device to determine device susceptibility to corrosion. ... response to proton pump inhibitor therapy, were ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

168

FDA Oysters bro. SP  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... Qué me está pasando?” Rosa: “Tienes mucha fiebre. Mejor que vayamos al hospital”. Page 5. 5 ... Síntomas: • Diarrea • Fiebre alta ... More results from www.fda.gov/downloads/food/foodborneillnesscontaminants

169

FDA News for Educators  

Center for Food Safety and Applied Nutrition (CFSAN)

Text VersionPage 1. News for Educators Center for Food Safety and Applied Nutrition Food Safety Nutrition Cosmetics July 2013 The Heat Is On! ... More results from www.fda.gov/downloads/food/newsevents

170

FDA Procedures for  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... pH meter; (6) Water activity meter; (7) Camera; and (8 ... an observation or take a measurement and fails ... Plumbing installed; proper backflow devices ... More results from www.fda.gov/downloads/food/guidanceregulation

171

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... system indicated for measuring pulmonary artery pressures in patients ... provides information to compensate for changes in atmospheric pressure. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

172

FDA Executive Summary (DRAFT)  

Center for Biologics Evaluation and Research (CBER)

Text Version... to assess changes in cerebral blood flow, and ... multiple post hoc, unadjusted analyses and found ... to the stroke-related mortality analysis, this was a ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

173

CRDAC FDA Backgrounder  

Center for Biologics Evaluation and Research (CBER)

Text Version... DRAFT POINTS TO CONSIDER ... Uric acid at baseline and minimum and maximum values in ... MAP) at scheduled clinic visits up to point of exposure ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

174

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... Hurricanes, tornadoes, earthquakes, and other natural disasters may result in interruptions to routing and transport whether by air, land, or water. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

175

DRAFT FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... and described reasons for failure [5, 6]. These two papers used the same dataset, which contained 59 patients with 78 hydroxyapatite-coated blade ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

176

FDA Panel Meeting  

Center for Biologics Evaluation and Research (CBER)

Text Version... procedure performed for end stage ... the ability to perform objective functional measurements. ... Page 141. Subject Performance Composite ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

177

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... The ordinal logistic regression model resulted in a ... a random effect distribution, the sponsor ... can be given separate random effects distributions. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

178

FDA Briefing Document  

Center for Biologics Evaluation and Research (CBER)

Text Version... open-label, randomized, controlled trial in 672 patients with ovarian cancer previously treated with only 1 platinum based chemotherapy regimen ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

179

FDA Drug Workshop  

Center for Drug Evaluation (CDER)

Text Version... Mastering Regulatory Compliance ? Let us consider your Shop - Home town, USA ? Small shop ... A History of Validation in the United States ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

180

FDA News for Educators  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... Drugs are products used for diagnosis, cure, mitigation, treatment, or prevention of disease, and intended to affect the structure or any function of ... More results from www.fda.gov/downloads/food/resourcesforyou

181

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... energy is non-programmable except for the shocks delivered manually or during induction testing (The device has a shock polarity algorithm which ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

182

FDA News for Educators  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... are hospitalized, and 3,000 die of foodborne diseases each year. ... the estimated 3 million Americans suffering from celiac disease – or preparing ... More results from www.fda.gov/downloads/food/resourcesforyou

183

FDA Draft Action Plan  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... History. Swedish report, April 24, 2002; CFSAN method, June 20, 2002; WHO/FAO consultation, June 25-27, 2002; ... 30, 2002. History II. ... More results from www.fda.gov/downloads/food/foodborneillnesscontaminants

184

FDA 1997 Pesticide Report  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... (7) Pennington, JAT (1992) Total Diet Studies: the identification of ... 1990 revision of the Food and Drug Administration's Total Diet Study. ... Cucumbers ... More results from www.fda.gov/downloads/food/foodborneillnesscontaminants

185

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... Mouse Bone Marrow Micronucleus Study Saline, sesame oil ... Mass Spectrometry)analysis showed no semi-volatile organic compounds in the ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

186

FDA Announces Educational Forums  

Center for Food Safety and Applied Nutrition (CFSAN)

... of the Association of Food and Drug Officials, titled “Leading the Way to Building Global Integrated Food, Drug, and Medical Device Safety Systems ... More results from www.fda.gov/food/newsevents/constituentupdates

187

FDA Alert [date]:  

Center for Drug Evaluation (CDER)

Text Version... Razadyne is approved as a treatment for mild to moderate Alzheimer's disease but not for mild cognitive impairment. Data Summary ... More results from www.fda.gov/downloads/drugs/drugsafety

188

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... The screening exam can consist of full field digital mammography (FFDM) alone or the combination of FFDM with digital breast tomosynthesis (DBT ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

189

FDA'S SAFE USE INITIATIVE  

Center for Drug Evaluation (CDER)

Text Version... Opioid Abuse on Young Children, Annals of ... Department Visits Among Children, American Journal of ... advertising and promotion; and postmarket ... More results from www.fda.gov/downloads/drugs/drugsafety

190

FDA PI1  

Center for Drug Evaluation (CDER)

Text Version... was 31% in 27 patients with squamous histology and 4% in patients with adenocarcinoma 28 receiving AVASTIN as compared ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

191

Comments FDA Sedation Workshop  

Center for Drug Evaluation (CDER)

Text Version... For over 20 years I have been head of the Section for Ambulatory Anesthesia for the Anesthesia Institute at the Cleveland Clinic in Cleveland, Ohio. ... More results from www.fda.gov/downloads/drugs/newsevents

192

FDA Meetings on Resistance  

Center for Drug Evaluation (CDER)

Text Version... Previously Granted Resistance Claims. Methicillin resistant S. aureus (MRSA): vancomycin in serious infections; linezolid in HAP and cSSSI. ... More results from www.fda.gov/downloads/drugs/drugsafety

193

FDA ODAC Transcript  

Center for Biologics Evaluation and Research (CBER)

Text Version... Johns Hopkins Johns Hopkins School of Medicine ... Action and the National Women's Health Network. MR. ... during lunch. Thank you. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

194

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... Cycles (5 years equivalent, amount of cycling typical for tissue valves); • Dynamic Failure Mode Testing; and • Finite Element Analysis (FEA) with In ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

195

FDA Briefing Document  

Center for Biologics Evaluation and Research (CBER)

Text Version... Further confounding the study, the low calcium diet itself increased markers of proliferation in the adrenal medulla and kidney cortex/outer medulla ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

196

FDA Briefing Document - EMDAC  

Center for Biologics Evaluation and Research (CBER)

Text Version... VADT(10) (Veterans Affairs Diabetes Trial) and ADVANCE(11) (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

197

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... disorders • Previous refractive procedures that prevent accurate IOP measurements (eg, PRK, LASIK) • Prior cataract surgery • Split fixation by ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

198

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... to fretting corrosion and galvanic corrosion, other ... transcatheter aortic valve replacement patients in ... such as other valve replacements, CABG, atrial ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

199

FDA Briefing Package  

Center for Biologics Evaluation and Research (CBER)

Text Version... edema, HAE can also cause significant morbidity. ... 3 intra-molecular disulfide bonds, with a ... 0.76 mg disodium hydrogen orthophosphase (dihydrate ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

200

FDA Briefing Package  

Center for Biologics Evaluation and Research (CBER)

Text Version... musculoskeletal and renal activities are each ... that improvement in disease activity is not ... clinical laboratory measures, physical examination, and ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

201

FDA Advisory Committees  

Center for Drug Evaluation (CDER)

Text Version... AC Process – Before AC – Day of AC • MIDAC – What is MIDAC? ... Page 22. Before the AC Business Days Before Meeting Event(s) 55 ... More results from www.fda.gov/downloads/drugs/scienceresearch

202

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... either subcutaneous low molecular weight heparin (LMWH ... to the Medical Management control at ... and post ablation diffusion weighted MRI imaging ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

203

FDA Patient Representative Program  

Center for Biologics Evaluation and Research (CBER)

Text Version... Relations: 1996 - 2000 Managed key regional bank ... Summit Bank (now Wells Fargo): Vice President ... Officer and Retail Banking Customer Contact ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

204

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... Each battery contains lithium ion cells that, when fully charged, can power ... all enrolled patients who underwent anesthesia for implantation of the ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

205

FDA NEWS RELEASE  

Center for Drug Evaluation (CDER)

Text Version... Media Contacts: Karen Riley, 301-796-4674 ... New summaries will be posted quarterly. Design Features Make Reviewing Summary Safety Reports ... More results from www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation

206

FDA's Participation in Codex  

Center for Food Safety and Applied Nutrition (CFSAN)

... and articulate clear US Delegation positions that enhance and promote consumer protection and reflect input by all stakeholders on matters before ... More results from www.fda.gov/food/internationalinteragencycoordination/internationalcooperation

207

FDA Flawed Gate Keeping  

Center for Drug Evaluation (CDER)

Text Version... Thomas Laughren, 2006 “the pooled estimates of studies of the adult ... 2004 Vioxx (rofexoxib) 2005 Adderall XR (amphetamine) withrawn in Canada ... More results from www.fda.gov/downloads/drugs/drugsafety

208

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... Champion™ Electronics System and Database - The Electronics System acquires and processes signals from the Implantable Sensor/Monitor ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

209

FDA Public Workshop  

Center for Drug Evaluation (CDER)

Text Version... simultaneous measurement of desired and toxic effects ... incorporated in the measurement • Threshold, effec[ve, and toxic concentra[ons ... More results from www.fda.gov/downloads/drugs/newsevents

210

FDA Center Priority Projects  

Center for Biologics Evaluation and Research (CBER)

Text Version... Further, due to their labile nature, they cannot safely be ... levels to evaluate levels of endotoxins, metal contaminants, organic contaminants, foreign ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

211

FDA Confocal microscopy- Polydefkis  

Center for Drug Evaluation (CDER)

Text Version... fiber could appear and disappear several times as it moves in and out of the focus plane. • This movement can affect the visual diameter and the ... More results from www.fda.gov/downloads/drugs/newsevents

212

FDA Oysters bro. SP  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... El alcoholismo y las infecciones de la hepatitis pueden dañar al hígado y deteriorar sus años de funcionamiento antes de que una persona ... More results from www.fda.gov/downloads/food/resourcesforyou

213

FDA Alert [date]:  

Center for Drug Evaluation (CDER)

Text Version... showed ground glass infiltrates, consistent with acute respiratory distress syndrome. The patient expired of multi-organ system failure about 19 ... More results from www.fda.gov/downloads/drugs/drugsafety

214

FDA Day 2.ptx  

Center for Drug Evaluation (CDER)

Text Version... disaster plan. It's 4 not only the floods and the fires and backing up your 5 data but it's really if you have a key staff person, 6 ... More results from www.fda.gov/downloads/drugs/newsevents

215

DRAFT FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... seizures. The most common example of a complex partial seizure is that originating in the mesial temporal region. This ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

216

Facts@FDA  

Center for Drug Evaluation (CDER)

... Download All Drug Labels (zip files). ... Page Last Updated: 01/30/2012 Note: If you need help accessing information in different file formats, see ... More results from www.fda.gov/drugs/resourcesforyou/healthprofessionals

217

FDA-Defined Valvulopathy  

Center for Biologics Evaluation and Research (CBER)

Text Version... Bulimia • Anorexia nervosa • Serious personality disorder ... bulimia or anorexia nervosa, CNS tumor – clinical situations: excessive use of alcohol or ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

218

FDA Drug Safety Newsletter Issues  

Center for Drug Evaluation (CDER)

... FDA, US Food and Drug Administration. US Food & Drug Administration. A to Z Index; ... FDA Drug Safety Newsletter Issues. Newsletter Issues. ... More results from www.fda.gov/drugs/drugsafety/drugsafetynewsletter

219

FDA Advisory Committees General Concepts  

Center for Biologics Evaluation and Research (CBER)

Text Version... FACA Final Rule on AC Management (2001) • 21 CFR Part 14 (FDA Regulation) • FDA Amendments Act (2007) • Ethics Laws and Regulations ... More results from www.fda.gov/downloads/advisorycommittees/aboutadvisorycommittees

220

FDA Safety Update: Asthma Medications  

MedlinePLUS

... to Z Index Follow FDA FDA Voice Blog Enter Search terms Search the FDA Archive Home Food Drugs Medical ... is no longer maintained and may be outdated. Enter Search terms For Consumers Home For Consumers Consumer Updates Section ...

221

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... Division of Anesthesia and Analgesia Products Office of Drug Evaluation II (ODE II) CDER, FDA 9:50 am FDA/CDER Education Campaigns Ellen ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

222

FDA 101: Smoking Cessation Products  

MedlinePLUS

... to Z Index Follow FDA FDA Voice Blog Enter Search terms Search the FDA Archive Home Food Drugs Medical ... is no longer maintained and may be outdated. Enter Search terms For Consumers Home For Consumers Consumer Updates Section ...

223

June 29, 2012: Meeting Presentations  

Center for Biologics Evaluation and Research (CBER)

... Freimuth - Patterns of Response to Health Risks Among Southern Poor 06/29/12 - Slides (PDF - 484KB). -. -. -. Page Last ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/riskcommunicationadvisorycommittee

224

Shakespearean Slide Shows.  

ERIC Educational Resources Information Center

|Presents a condensed method for involving students in the kind of theatrical problem-solving that transforms a script to a play. Describes how to incorporate a "human slide show" into the class. Notes that students must read plays not just to understand events, but to make artistic choices about how to stage the action so that an audience…

Flynn, Rosalind M.

2002-01-01

225

FDA ENCOURAGES NEW DRUG APPLICATION ...  

Center for Drug Evaluation (CDER)

... FDA ENCOURAGES NEW DRUG APPLICATION SUBMISSIONS FOR PRUSSIAN BLUE AS A TREATMENT FOR THALLIUM OR RADIOACTIVE ... More results from www.fda.gov/drugs/emergencypreparedness/bioterrorismanddrugpreparedness

226

AASLD-FDA-NIH-PhRMA*- Hepatotoxicity Special Interest ...  

Center for Drug Evaluation (CDER)

... AASLD-FDA-NIH-PhRMA*- Hepatotoxicity Special Interest Group Meeting, 2007 Presentations: Pre-existing liver disease DOES make DILI more ... More results from www.fda.gov/drugs/scienceresearch/researchareas

227

AASLD-FDA-NIH-PhRMA*- Hepatotoxicity Special Interest ...  

Center for Drug Evaluation (CDER)

... AASLD-FDA-NIH-PhRMA*- Hepatotoxicity Special Interest Group Meeting, 2007 Presentations: Industry commentary on concept paper (Stern). ... More results from www.fda.gov/drugs/scienceresearch/researchareas

228

AASLD-FDA-NIH-PhRMA*- Hepatotoxicity Special Interest ...  

Center for Drug Evaluation (CDER)

... AASLD-FDA-NIH-PhRMA*- Hepatotoxicity Special Interest Group Meeting, 2008 Presentations: Liver test elevations seen in patients on placebo. ... More results from www.fda.gov/drugs/scienceresearch/researchareas

229

AASLD-FDA-NIH-PhRMA Hepatotoxicity Steering Group ...  

Center for Drug Evaluation (CDER)

... AASLD-FDA-NIH-PhRMA Hepatotoxicity Steering Group Meeting, 2006 Presentations: New developments in preclinical prediction of human ... More results from www.fda.gov/drugs/scienceresearch/researchareas

230

Slides from the January 13, 2010 Meeting of the ...  

Center for Biologics Evaluation and Research (CBER)

... FDA. FDA Core Presentations, (NDA) 22-562, CARBAGLU (carglumic acid) Tablets, Orphan Europe, SARL, for the January 13, 2010 Meeting of the ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

231

FDA Food Code 2009: Chapter 3 - Food  

Center for Food Safety and Applied Nutrition (CFSAN)

... Pf. 3-6 Food Identity, Presentation, and On-premises Labeling. Subparts. ... Accurate Representation. 3-601.11 Standards of Identity. ... More results from www.fda.gov/food/guidanceregulation/retailfoodprotection

232

Appendix 1 Procedures Requesting Speakers FDA CBER ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Meeting organizer(s) • Topic of meeting and topic of speaker presentation ... Draft agenda naming all speaker invited and topics ... More results from www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation

233

FDA CENTER FOR DRUG EVALUATION AND RESEARCH  

Center for Biologics Evaluation and Research (CBER)

Text Version... This was due to the poor film quality (paper PDF ... severe) OA which, coupled with poor quality images ... data were present in only a minority of cases. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

234

Guidance for FDA Reviewers: Premarket Notification ...  

Center for Biologics Evaluation and Research (CBER)

... basic elements are present to conduct an evaluation ... of operations Power source Heating and cooling ... of the specific tests conducted in accordance ... More results from www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances

235

MADIT-CRT - FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... event excluding LVESVI events. This analysis will be presented later with other additional key analyses. The Panel will be ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

236

FDA Recommends Against Prolonged Use of Magnesium ...  

Center for Drug Evaluation (CDER)

Text Version... Magnesium is an essential mineral present in ... The metabolism and distribution of other minerals in the body such as calcium and potassium are ... More results from www.fda.gov/downloads/drugs/drugsafety

237

5th Annual FDA and the Changing Paradigm for HCT/P ...  

Center for Biologics Evaluation and Research (CBER)

... Transcripts & Minutes (Biologics). -. 5th Annual FDA and the Changing Paradigm for HCT/P Regulation. -. Presentations. Writing ... More results from www.fda.gov/biologicsbloodvaccines/newsevents/workshopsmeetingsconferences

238

FDA Oysters bro.  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... After a few more days in the hospital, Carlos is well enough to go home with ... oysters that you are putting your life at risk.” Rosa: “Yes, I'm going to tell ... More results from www.fda.gov/downloads/food/resourcesforyou

239

FDA Meeting: Transcript  

Center for Drug Evaluation (CDER)

Text Version... Well, in the early 22 '60s, there were high-profile cases of data fraud that (866) 448 - DEPO www.CapitalReportingCompany.com © 2010 Page 15. ... More results from www.fda.gov/downloads/drugs/newsevents

240

FDA NDAC and PDAC  

Center for Biologics Evaluation and Research (CBER)

Text Version... 42 we have both solid and liquid, oral, immediate- ... 21 22 Now, I had thought that there were three ... 3-year-old has become fussy and a little feverish ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

241

FDA Authority Over Cosmetics  

MedlinePLUS

FDA Authority Over Cosmetics March 3, 2005; updated August 3, 2013 In the United States, federal laws are enacted by Congress. In order ... license to operate? What kinds of products are “cosmetics” under the law? The FD&C Act defines ...

242

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... 7.1 'References 7.2 Propofol Label 7.3 Hemoglobin Saturation Relationship to Arterial Oxygen Tension 7.4 List of Clinical Studies 7.5 Abbreviations ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

243

FDA Briefing Material  

Center for Biologics Evaluation and Research (CBER)

Text Version... Seroquel XR was superior to placebo (Pbo: -13.1; Seroquel XR: -16.5; mean daily dose was 162 mg/day). ... Q-LES-Q, LS mean change from ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

244

FDA/ ASCO/AACR  

Center for Drug Evaluation (CDER)

Text Version... Dr. Robert F. Ozols of Fox Chase Cancer Center and Dr. David R. Spriggs of Memorial Sloan- Kettering ... Stuart G, Avall-Lundqvist E, du Bois A, et al. ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

245

Raxibacumab FDA Introductory Remarks  

Center for Biologics Evaluation and Research (CBER)

Text Version... P value? 0.0998 * 2-sided likelihood ratio chi-square test 28 ... Comparable by sex, weight, & age ... 28 normal by Day 7 PC • Majority of dead animals in ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

246

FDA Antiviral Drugs  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. 1 FOOD AND DRUG ADMINISTRATION 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 CENTER FOR ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

247

FDA Executive Summary Memorandum  

Center for Biologics Evaluation and Research (CBER)

Text Version... Deciding when to stop a trial One can use a ... an interim point as the rule for stopping the trial ... the interim point), the trial may be stopped and declared ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

248

FDA Executive Summary  

Center for Biologics Evaluation and Research (CBER)

Text Version... surgery lasted 1.8 hours, and the longest lasted 8.2 ... and the surgeon is no longer at the ... Baseline through Unblinded Phases), 42 (Long-term Follow ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

249

Slide Layout and Integrated Design (Slide) Program.  

National Technical Information Service (NTIS)

SLIDE is a FORTRAN IV program for producing 35 mm color slides on the Control Data CYBER-74. SLIDE interfaces with the graphics package, DISSPLA, on the CYBER-74. It was designed so that persons with no previous computer experience can easily and quickly ...

S. G. Roberts

1975-01-01

250

How FDA Evaluates Regulated Products: Cosmetics  

MedlinePLUS

... Webinar Series Children FDA Basics Metrics Watch: FDA Basics Videos ? - Resources for You FDA Basics: Cosmetics Product and ... safety? How FDA Evaluates Regulated Products: Cosmetics FDA Basics Video: Ensuring That Cosmetics Used in the United States ...

251

FDA Drug Safety Communication: FDA limits duration and ...  

Center for Drug Evaluation (CDER)

... Hy's law is a prognostic indicator that FDA follows to evaluate the potential for drug-induced severe liver injury and typically refers to significant ... More results from www.fda.gov/drugs/drugsafety

252

FDA Drug Safety Communication: FDA requires post-market ...  

Center for Drug Evaluation (CDER)

... Drug Administration (FDA) is requiring the manufacturers of LABAs to conduct five randomized, double-blind, controlled clinical trials comparing the ... More results from www.fda.gov/drugs/drugsafety

253

FDA Drug Safety Podcast: FDA Warns Consumers to Avoid ...  

Center for Drug Evaluation (CDER)

... On August 26, 2010, the Food and Drug Administration (FDA) issued an alert ... TimeOut contains a chemical similar to the active ingredient in Viagra. ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

254

FDA Drug Safety Podcast: FDA investigating reports of ...  

Center for Drug Evaluation (CDER)

... the drug labels and the patient Medication Guides for ... FDA has not concluded these drugs may cause ... A link to this communication can be found at ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

255

FDA Drug Safety Communication: FDA is investigating two ...  

Center for Drug Evaluation (CDER)

The US Food and Drug Administration (FDA) is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic ... More results from www.fda.gov/drugs/drugsafety

256

FDA Talk Paper: FDA Warns Against Women Using ...  

Center for Drug Evaluation (CDER)

... The Agency also is issuing an Import Alert which alerts FDA field personnel to be on the lookout for attempts to import this drug so that it can be ... More results from www.fda.gov/drugs/drugsafety/informationbydrugclass

257

FDA Drug Safety Podcast for Healthcare Professionals: FDA ...  

Center for Drug Evaluation (CDER)

... FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients. ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

258

FDA Drug Safety Podcast for Healthcare Professionals: FDA ...  

Center for Drug Evaluation (CDER)

... FDA continues to receive reports of a rare, but serious and potentially fatal adverse effect with the use of benzocaine sprays for medical procedures. ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

259

1. What is FDA announcing? On October, 3, 2007, FDA ...  

Center for Drug Evaluation (CDER)

Text Version... On October, 3, 2007, FDA approved labeling revisions for Accutane (isotretinoin) that incorporate modifications in iPLEDGE, the risk management ... More results from www.fda.gov/downloads/drugs/drugsafety

260

FDA Drug Safety Podcast: FDA Reduces Dose of ...  

Center for Drug Evaluation (CDER)

... Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site WWW dot FDA dot GOV slash DRUGS. ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

261

February 19, 2009 FDA Topic 3: FDA Briefing Document ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Topic 3: FDA Briefing Document: Clinical Trials in Children of Vaccines to Prevent Disease Caused by Influenza Viruses with Pandemic Potential. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

262

FDA Talk Paper - FDA Approves Pediatric Doses of Atropen  

Center for Drug Evaluation (CDER)

... Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA. ... forms of the Atropen (atropine autoinjector) for use in children and adolescents ... More results from www.fda.gov/drugs/emergencypreparedness/bioterrorismanddrugpreparedness

263

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... FDA Participants (Non-Voting): Victoria Kusiak, MD; Joyce Korvick, MD, MPH; Claudia Manzo, PharmD; Gary Slatko, MD, MBA, Mary Willy, PhD ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

264

FDA IT and Informatics Transformation  

Center for Biologics Evaluation and Research (CBER)

Text Version... Page 8. FDA's Move to the Cloud Next-Generation Sequencing Private Cloud – Modernized Data Center – 89.1 % Virtualized – Increased ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

265

FDA Drug Safety Communication: Prescription ...  

Center for Drug Evaluation (CDER)

... acetaminophen (eg, Tylenol) are not affected by this ... Report side effects to FDA's MedWatch program using ... patients not to drink alcohol while taking ... More results from www.fda.gov/drugs/drugsafety

266

FDA Drug Safety Podcast: Ameridose  

Center for Drug Evaluation (CDER)

... is an FDA drug safety alert from the Division of Drug Information. ... Ameridose shares common management by the same parties as New England ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

267

Transcript: FDA Opioid Conversion Workshop  

Center for Drug Evaluation (CDER)

Text Version... FDA Opioid Conversion Workshop 07-29-2013 1 want to get into the weeds, but erudite transformation 2 that allowed them to do that calculation. ... More results from www.fda.gov/downloads/drugs/newsevents

268

FDA APPROVES PYRIDOSTIGMINE BROMIDE AS ...  

Center for Drug Evaluation (CDER)

... During the Gulf War, FDA had allowed distribution of pyridostigmine bromide under its Investigational New Drug provisions because pretreatment ... More results from www.fda.gov/drugs/emergencypreparedness/bioterrorismanddrugpreparedness

269

FDA Risk Communication Research Agenda  

Center for Biologics Evaluation and Research (CBER)

Text Version... by members of the FDA's internal Communication Council and ... To what degree do medical ... action on different types of communications (eg, recalls ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

270

FDA Nanotechnology Regulatory Science Program  

Center for Biologics Evaluation and Research (CBER)

Text Version... Develop Criteria for Review – Application to Targeted Topic Areas ... Applications Nanomedicine Novel Foods ... Page 24. 24 FDA's Nanotechnology ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

271

DRAFT FDA Form 2541f  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... Food Process Filing for Water Activity/Formulation Control Method (Form FDA 2541f) ... Syrup Water None (ie, the product is all liquid) ... More results from www.fda.gov/downloads/food/guidanceregulation

272

FDA FSMA and Small Business  

Center for Food Safety and Applied Nutrition (CFSAN)

... Importer Reinspection User Fee Rates for Fiscal Year 2012 Notice; Request For Comments Docket Number: FDA-2011-N-0528, Correction Notice. ... More results from www.fda.gov/food/guidanceregulation/fsma

273

ASH/FDA Workshop on  

Center for Drug Evaluation (CDER)

Text Version... MA ASH Liaison James N. George, MD University of Oklahoma Health Sciences Center Oklahoma City, OK FDA Representative ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

274

FDA Update: High Country Meeting  

Center for Drug Evaluation (CDER)

Text VersionPage 1. 2012 FDA Update “High Country Meeting” March 5, 2012/11:30 EST Dwaine Rieves, MD Director, Division of Medical Imaging Products 1 ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

275

Slides for the November 2, 2012 Meeting of the Anti-Infective ...  

Center for Biologics Evaluation and Research (CBER)

... ASPR Slides for the November 2, 2012 Meeting of the Anti-Infective Drugs Advisory Committee (PDF - 135KB). Human Genome Sciences, Inc. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

276

Slides for the June 5-6, 2013 Joint Meeting of the ...  

Center for Biologics Evaluation and Research (CBER)

... Slides for the June 5-6, 2013 Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) and Drug Safety and Risk ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

277

Slides for the November 28, 2012 Meeting of the Anti-Infective ...  

Center for Biologics Evaluation and Research (CBER)

... Anti-Infective Drugs Advisory Committee Roster. -. Slides for the November 28, 2012 Meeting of the Anti-Infective Drugs Advisory Committee. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

278

Presentations  

Cancer.gov

Presentations Name Position Presentation (ppt) Sudhir Srivastava, PhD, MPH Chief, Cancer Biomarkers Research Group Metabolomics: An Untapped Frontier (ppt, 161kb) John Milner, PhD Chief, Nutritional Sciences research Group Can Metabolomics

279

DRAFT FDA Form 2541g  

Center for Food Safety and Applied Nutrition (CFSAN)

Text VersionDraft Issued for Comment Only. Do Not Use to Submit a Process Filing to FDA ... Do Not Use to Submit a Process Filing to FDA Wine Cooler; Other ... More results from www.fda.gov/downloads/food/guidanceregulation

280

Songs and Slides---Or Slides and Songs?  

ERIC Educational Resources Information Center

|Presents a variety of songs in which songs and slides can be used in a multinational classroom, providing pronunciation practice and a basis for free conversation and discourse, thus improving fluency. Visual and audio cues are presented simultaneously and in sequence, thus varying the presentation. Technical aspects are also discussed. (PJM)|

Belsey, Valerie; Wellington, Jane

1980-01-01

281

February 22, 2010: Science Board to the FDA Meeting ...  

Center for Biologics Evaluation and Research (CBER)

... Public Participation and Sponsor Information. Interested persons and Sponsors (representatives from industry) may present data, information, or ... More results from www.fda.gov/advisorycommittees/calendar

282

GRAY Slides DIA Annual Meeting 2012  

Center for Drug Evaluation (CDER)

Text Version... individual presenter and are protected under the copyright laws of ... Promotional Labeling Advertising Original Resubmission Amendment ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

283

Questions and Answers on FDA's Postmarketing Safety ...  

Center for Drug Evaluation (CDER)

... Contact FDA. 1-800-332-1088. 1-800-FDA-0178 Fax. Report a Serious Problem MedWatch Online. Regular Mail: Use postage-paid FDA Form 3500 ... More results from www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance

284

FDA Drug Safety Communication: FDA requires label changes ...  

Center for Drug Evaluation (CDER)

... patients exposed to these medications, cannot be ... manufacturers of systemic fluoroquinolone drugs to make ... sections) and the Medication Guides. ... More results from www.fda.gov/drugs/drugsafety

285

FDA Drug Safety Podcast: FDA is investigating two deaths ...  

Center for Drug Evaluation (CDER)

... High doses of olanzapine can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and reduced level of consciousness ranging from ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

286

Science at the FDA: Update for the FDA Science Board  

Center for Biologics Evaluation and Research (CBER)

Text Version... Examples: Science of small clinical trials, liver toxicity knowledge base, gold nanoparticles from a regulatory science ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

287

FDA Drug Safety Communication: FDA warns of rare but ...  

Center for Drug Evaluation (CDER)

... drug (NSAID) in Emergency Medical Center. ... Risk factors for acute generalized exanthematous ... assessment of medication risks with emphasis on ... More results from www.fda.gov/drugs/drugsafety

288

FDA/NIST Sponsored Workshop  

Center for Biologics Evaluation and Research (CBER)

Text Version... Centers for Medicare and Medicaid Services (CMS) Environmental Protection Agency (EPA) ... Environment • Developing Enabling Tools ... More results from www.fda.gov/downloads/biologicsbloodvaccines/newsevents

289

FDA Modernization Act (FDAMA) Claims  

Center for Food Safety and Applied Nutrition (CFSAN)

... 2001. Fluoride and the Risk of Dental Caries: Health Claim Notification for Fluoridated Water October 14, 2006. Potassium ... More results from www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition

290

FDA IRB & Informed Consent Regulations  

Center for Drug Evaluation (CDER)

Text Version... applications. – For regulatory decision making (Approval) – As evidence base for clinical use of drug (Label) – Evaluating ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

291

Glacier Sliding With Cavitation Over Irregular Beds  

NASA Astrophysics Data System (ADS)

Pressurised subglacial water affects the sliding of glaciers over hard beds through the process of cavitation. In particular, it is widely recognised that sliding velocities depend not only on shear stress but also on the difference pe between overburden and drainage pressures. However, the precise form which such a sliding law should take is unclear, and many modellers opt for a heuristic power-law ub = C? bn pe-m. Here we show how Iken's (J. Glaciol., 27, 407-422) notion of a `critical pressure' at which sliding becomes unstable can be re-interpreted as an upper bound on the amount basal shear stress which a hard bed can support. Such an upper bound clearly contradicts the sliding law above. Motivated by the need to construct a more realistic sliding law which is not in conflict with Iken's bound, we present an analysis of hard bed sliding in the presence of cavitation which extends Fowler's (Proc. R. Soc. L. Ser. A., 407, 147--170) treatment to the case of irregular beds with many different bump sizes. Our results imply that generalised power-law sliding laws should not be used indiscriminately, particularly when discussing surge-type glacier flow. Furthermore, our results highlight the need to incorporate improved drainage models into the theory of hard bed sliding.

Schoof, C.

2002-12-01

292

FDA/CFSAN - FDA 2001 Food Code - Errata  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... that are listed in the FDA monograph for OTC Health-Care Antiseptic Drug ... 5°C (41°F) and 7°C (45°F) for a maximum of 4 days in existing ... The day of ... More results from www.fda.gov/downloads/food/guidanceregulation

293

A Guide to the FDA.  

ERIC Educational Resources Information Center

|The United States Food and Drug Administration (FDA) collects information in seven areas: foods, cosmetics, human drugs, animal drugs and feeds, medical devices, biologics, and electronic radiological products. By using procedures outlined in the Freedom of Information Act, the public may get specific information from such FDA files as inspection…

Miller, Annetta K.

294

FDA Almanac, Fiscal Year 1997.  

National Technical Information Service (NTIS)

Foods and drugs. While it might seem that the mission of the Food and Drug Administration is summed up in those two words, the FDA story is about much more than the agency's name suggests. This FDA Almanac provides a wealth of facts and figures that show ...

1997-01-01

295

FDA Almanac, Fiscal Year 1992.  

National Technical Information Service (NTIS)

The FDA Almanac provides a wealth of facts and figures that show both how the agency has fulfilled its regulatory mandates in the past year as well as the breadth of FDA's impact in public health protection. The data in the book also demonstrate that whil...

1992-01-01

296

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. FOOD AND DRUG ADMINISTRATION (FDA) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 CENTER ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

297

Slide 1  

Cancer.gov

WHY PHYSICIANS BURN OUT? AZIZA SHAD, MD MECC PALLIATIVE CARE MEETING LARNACA, JUNE 2007 CASE PRESENTATION Subject: Aziza Shad, MD • Job description: – Academic Physician – Clinical Researcher – Chief of Division – Mother of 3 children – Wife of an academician CASE

298

Seismic analysis of sliding structures.  

National Technical Information Service (NTIS)

To limit the seism effects, structures may be base isolated. A sliding system located between the structure and the support allows differential motion between them. The aim of this paper is the presentation of the method to calculate the response of the s...

D. Brochard F. Gantenbein

1989-01-01

299

Slide structure and role of gas hydrate at the northern boundary of the Storegga Slide, offshore Norway  

Microsoft Academic Search

The Storegga Slide off the coast of Norway is one of the largest underwater slide complexes known and has been proposed as a significant source of past methane release into the atmosphere. We present pre-stack depth-migrated images from a new multi-channel seismic data set in the Storegga Slide. The northern scarp of the Storegga Slide has previously been interpreted as

Hillary E. Brown; W. Steven Holbrook; Matthew J. Hornbach; Jeffrey Nealon

2006-01-01

300

Sliding Pi  

NSDL National Science Digital Library

"The entrance to the Downsview subway station in Toronto presents visitors with a striking vista. A vast mosaic of square tiles sweeps across a curved wall, inviting viewers to trace its lines and ponder intriguing irregularities in its color scheme of blues, greens, roses, and other hues... The artist is Arlene Stamp, now a resident of Calgary, Alberta. In 1993, at the height of her interest in nonperiodic patterns, she was intrigued by the possibility of using such designs in public spaces for enlivening large areas, such as floors and walls, more often covered with simple, repeating motifs..."

Peterson, Ivars

2007-03-05

301

FDA Genomics Working Group Update to the FDA Science ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Each Center/ORA Office of Chief Scientist Office of Information Management Senior Science Council Scientific Computing Board ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

302

FDA Drug Safety Communication: FDA limits usage of Nizoral ...  

Center for Drug Evaluation (CDER)

Text Version... to potentially fatal liver injury and risk of drug interactions and adrenal gland problems Safety Announcement ... Liver Injury (Hepatotoxicity) ... More results from www.fda.gov/downloads/drugs/drugsafety

303

FDA Public Hearing on FDA-Approved Labeling for Opioid ...  

Center for Drug Evaluation (CDER)

Text Version... pharmacies • Family members of loved one lost to opioid use, misuse, and abuse • Pharmaceutical manufacturers • Academia • Patient advocacy ... More results from www.fda.gov/downloads/drugs/newsevents

304

FDA Food Safety Modernization Act: A Primer by FDA (video ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... occur is critical given today's complex, global food supply and the emerging pathogens that are especially threatening to vulnerable populations. ... More results from www.fda.gov/food/guidanceregulation/fsma

305

FDA Drug Safety Communication: FDA investigating rare brain ...  

Center for Drug Evaluation (CDER)

... The patient who developed PML received nearly eight months of Gilenya ... with interferon beta-1a and azathioprine for one month before initiating ... More results from www.fda.gov/drugs/drugsafety

306

FDA Statement: FDA halts clinical trial of drug Revlimid ...  

Center for Drug Evaluation (CDER)

... ORIGIN trial (NCT00910910), which was evaluating Revlimid treatment for a new use as an initial therapy for chronic lymphocytic leukemia (CLL) in ... More results from www.fda.gov/drugs/drugsafety

307

FDA Drug Safety Podcast: FDA warns of increased risk of ...  

Center for Drug Evaluation (CDER)

... The adjusted risk difference for death was 0.6% with corresponding 95% confidence interval. In general, the deaths resulted from worsening ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

308

FDA Drug Safety Podcast: FDA investigating rare brain ...  

Center for Drug Evaluation (CDER)

... The diagnosis was made based on clinical symptoms and the detection of JC viral DNA in the cerebrospinal fluid. Gilenya treatment was stopped. ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

309

FDA Transparency Task Force FDA Transparency Task Force  

Center for Biologics Evaluation and Research (CBER)

Text Version... Page 2. Hypothetical Case Study 1.1 Hypothetical Case Study 1.1 ... Page 3. Hypothetical Case Study 1.1 Hypothetical Case Study 1.1 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

310

FDA Drug Safety Communication: FDA continues to receive ...  

Center for Drug Evaluation (CDER)

... and potentially fatal adverse effect, associated with ... Report side effects or medication errors from the ... A characteristic color of the blood (chocolate ... More results from www.fda.gov/drugs/drugsafety

311

FDA Science Board Subcommitte: Review of the FDA/CDER ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... PV practice and training, and harmonizing PV ... is later) post-approval safety evaluations for all ... Successful scientific evaluation of technologies and ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

312

FDA Drug Safety Podcast: FDA issues warnings to marketers ...  

Center for Drug Evaluation (CDER)

... their over-the-counter or OTC chelation products are unapproved drugs and devices. ... risks, and they should only be used with medical supervision. ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

313

FDA Drug Safety Communication: FDA limits usage of Nizoral ...  

Center for Drug Evaluation (CDER)

... or hepatotoxicity, with new assessment and monitoring ... for monitoring populations at risk (Warnings section). ... on the potential risks associated with ... More results from www.fda.gov/drugs/drugsafety

314

FDA Drug Safety Communication: FDA investigating reports of ...  

Center for Drug Evaluation (CDER)

... patients after they died from unspecified causes. ... concluded these drugs may cause or contribute ... in the National Institute of Diabetes and Digestive ... More results from www.fda.gov/drugs/drugsafety

315

FDA Drug Safety Podcast: FDA asks manufacturer of the ...  

Center for Drug Evaluation (CDER)

... a Drug Safety Communication notifying the public it has asked the manufacturer of the leukemia chemotherapy drug Iclusig (ponatinib) to suspend ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

316

FDA Drug Safety Communication: FDA asks manufacturer of ...  

Center for Drug Evaluation (CDER)

... website: Physician Request for an Individual Patient IND under Expanded Access for Non ... 1 and 2 clinical trials did not include a control group so it ... More results from www.fda.gov/drugs/drugsafety

317

FDA Drug Safety Podcast: FDA requiring color changes to ...  

Center for Drug Evaluation (CDER)

... to create awareness and educational opportunities for health care professionals, patients, and caregivers about the safe storage and proper ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

318

FDA Information Need: Data FDA Information Need: Data on ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... website, and through various mass media channels, such as website, and through various mass media channels, such as ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

319

FDA Drug Safety Podcast: FDA investigating leukemia drug ...  

Center for Drug Evaluation (CDER)

... such as chest pain or pressure, pain in their arms, back, neck or jaw ... artery disease, stroke, narrowing of large arteries of the brain, severe narrowing ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

320

FDA > CDRH > CFR Title 21 Database Search FDA Home ...  

Center for Biologics Evaluation and Research (CBER)

... when a committee member's ordinary pursuits are interrupted for the substantial portion of an additional day beyond the day or days spent in ... More results from www.fda.gov/downloads/advisorycommittees/aboutadvisorycommittees

321

Ergometer rowing with and without slides.  

PubMed

A rowing ergometer can be placed on a slide to imitate 'on-water' rowing. The present study examines I) possible differences in biomechanical and physiological variables of ergometer rowing with and without slides and II) potential consequences on training load during exercise. 7 elite oars-women rowed in a randomized order in a slide or stationary ergometer at 3 predefined submaximal and at maximal intensity. Oxygen uptake was measured and biomechanical variables of the rowing were calculated based upon handle force (force transducer) and velocity/length (potentiometer) of the stroke. Stroke frequency was higher (%-difference between conditions) at each intensity level (1-11.4%, p<0.05) during slide compared to stationary rowing. Furthermore, at the 2 highest intensities a lower mean force (4.7-9.0%, p<0.05) and max force (3.2-10.6%, p<0.05) were observed on the slide ergometer. During maximal rowing no difference was seen in heart rate, mean oxygen uptake and R-value while maximal oxygen deficit was higher (30.8%, p<0.05) during slide rowing. In conclusion the biomechanical load is lower on a slide than on a stationary ergometer. However, as a training tool the slide ergometer seems just as demanding with regard to aerobic energy sources, and for anaerobic sources possibly even higher, compared with the stationary ergometer. PMID:20827655

Holsgaard-Larsen, A; Jensen, K

2010-09-08

322

Slides for the March 20, 2012 Meeting of the Oncologic Drugs ...  

Center for Biologics Evaluation and Research (CBER)

... Morning Session. FDA. FDA Presentations, Votrient (pazopanib) tablets, for the March 20, 2012 Meeting of the Oncologic Drugs Advisory Committee ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

323

Slides for the May 2, 2013 Meeting of the Oncologic Drugs ...  

Center for Biologics Evaluation and Research (CBER)

... Afternoon Session. FDA. FDA Presentations, Melblez Kit, for the May 2, 2013 Meeting of the Oncologic Drugs Advisory Committee (PDF – 410KB). ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

324

Slides for the April 22, 2010 Joint Meeting of the Anesthetic ...  

Center for Biologics Evaluation and Research (CBER)

... FDA. FDA Core Presentations, ACUROX (oxycodone HCl and niacin) Tablets, for the April 22, 2010 Joint Meeting of the Anesthetic and Life Support ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs

325

FDA (Food and Drug Administration) Pesticide Analytical Manual. Volume 2.  

National Technical Information Service (NTIS)

The FDA Pesticide Analtical Manual is a laboratory manual describing methods for the analysis of pesticide residues in foods and feeds. Details are presented for the methods used by FDA to enforce the pesticide tolerances set by EPA. Periodic revisions ar...

1988-01-01

326

Adaptive seeking sliding mode control  

Microsoft Academic Search

This paper proposes a new sliding mode design concept, namely adaptive seeking sliding mode control for a class of nonlinear systems. While reserving the properties of the sliding mode control, like insensitivity to parameter variations and complete rejection of disturbances, adaptive seeking sliding mode control offers a promising robust sliding mode control solutions for real-life engineering applications with simple control

Hai Yu; U. Ozguner

2006-01-01

327

Slides: Intro to Nano  

NSDL National Science Digital Library

These are the slides from the webinar that was recorded 2/27/09. Description: This presentation will introduce you to some major concepts in nanotechnology, some meaningful applications, how fabrication is performed, and how one can benefit from gaining nanofabrication skills. It is meant to be a first introduction to the material for audiences that have little background knowledge of nanotechnology. Nanotechnology is enabling many fields to improve the knowledge and processing capabilities with innovative methods of fabrication at the nanoscale. The nanoscale is between 0-1000 nanometers but most of the unique properties are observed when structures have dimensions under 100 nm. This incredibly small size brings some new challenges but many beneficial rewards. We have selected three main discussion areas to share with you including: altering material properties, alternative medical treatments, and the impact on the food industry. Presenters: Robert K. Ehrmann, Director of Education & Outreachand Amy Brunner, Research/Outreach Associate

Ehrmann, Robert K.; Brunner, Amy

2011-06-02

328

Explaining the Storegga Slide  

Microsoft Academic Search

The Storegga Slide occurred 8200 years ago and was the last megaslide in this region where similar slides have occurred with intervals of approximately 100ky since the onset of continental shelf glaciations at 0.5Ma. A geological model for the Plio-Pleistocene of the area explains the large scale sliding as a response to climatic variability, and the seismic stratigraphy indicates that

Petter Bryn; Kjell Berg; Carl F. Forsberg; Anders Solheim; Tore J. Kvalstad

2005-01-01

329

FDA Transmissible Spongiform Encephalopathies Advisory ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... However, Saudi Arabia was identified as having imported live cattle and beef products from the UK during the period of concern (1980-1996) [24 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

330

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... Questions to the Committee Discussion/Vote ... (Voting question) a) In patients 18 years of age and ... Those members who voted “No” felt that there is a ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

331

FDA Food Code 2009: Preface  

Center for Food Safety and Applied Nutrition (CFSAN)

... as retail food stores, food service establishments, health care facilities, schools and other ... the public health by assuring the safety and security of our ... More results from www.fda.gov/food/guidanceregulation/retailfoodprotection

332

FDA Transcript: Chronic Pain Workshop  

Center for Drug Evaluation (CDER)

Text Version... know, what we don't know, and what the research agenda should be. So Bob? ... Again, one of the early ... So both these studies, the earlier two ... More results from www.fda.gov/downloads/drugs/newsevents

333

DRAFT FDA Form 2541e  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... Beverage Base; Breakfast Foods (liquid form – ready-to-eat, such as porridge, gruel); ... Syrup Water None (ie, the product is all liquid) ... More results from www.fda.gov/downloads/food/guidanceregulation

334

HHS FDA: Briefing on Avandia  

Center for Drug Evaluation (CDER)

... scientific advisory meetings and had technical discussions. ... Alicia Mundy from the Wall Street Journal. ... of the decision in leading medical journals. ... More results from www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders

335

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... Some members commented that MRI evidence of inflammation should focus only on the sacroiliac joints and not the spine. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

336

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... REMS Leonard Paulozzi, MD, MPH (Speaker) Impact Using Prescription Drug Division of Unintentional Injury Prevention Monitoring Program ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

337

FDA ORTHOPAEDIC AND REHABILITATION DEVICES ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Dr. Golish serves as the Section Editor for Basic Science and engineering for “OKO”, a monthly peer-reviewed journal from the American Academy ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

338

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (autosomal dominant ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

339

www.fda.gov/spottheblock  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... He loves salty snacks, but he also knows that salt (also called sodium) is a nutrient to get less of. FOR When choosing snacks ... More results from www.fda.gov/downloads/food/resourcesforyou

340

FDA 2001 Food Code - Errata  

Center for Food Safety and Applied Nutrition (CFSAN)

... 1-201.10(B)(38)(a), now reads, ...or other equine in 9 CFR 301 Definitions, as Poultry in 9 CFR 381 Poultry Products Inspection Regulations, or as ... More results from www.fda.gov/food/guidanceregulation/retailfoodprotection

341

Comments FDA Sedation Products Workshop  

Center for Drug Evaluation (CDER)

Text Version... difficult to evaluate the pre-approval studies for sedation products. One research issue has been to clearly separate product development goals ... More results from www.fda.gov/downloads/drugs/newsevents

342

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... control in adults with type 2 diabetes mellitus. ... Regulation of Glycemia in Diabetes (RECORD) Trial ... analyses performed on each of these two drugs. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

343

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... Washington, DC North/ Silver Spring 8727 Colesville Road, Silver Spring, MD ... as hospitalizations, a procedure using a breathing tube known as ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

344

FDA TPSAC AFLATOXIN REMEDIATION DOCUMENTS ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... An Alfatest immunoaffin- ity (IA) column was placed in the vacuum manifold and the storage buffer drained by gravity. Fifty milliliters plas- Page 7. - ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

345

FDA Executive Summary H080002  

Center for Biologics Evaluation and Research (CBER)

Text Version... PROCEDURAL EVENTS (WITHIN 24 HOURS POST IMPLANT), (N=7) ....27 7.4.1. Left Coronary Artery (LCA) Compression (n ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

346

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... Canagliflozin is a member of the sodium-glucose co-transporter 2 (SGLT2) inhibitors, and was developed as an adjunct to diet and exercise to ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

347

FDA's Concerns About Unapproved Drugs  

Center for Drug Evaluation (CDER)

... instance, the applicant must demonstrate that its manufacturing processes can reliably produce drug products of expected identity, strength, quality ... More results from www.fda.gov/drugs/guidancecomplianceregulatoryinformation/enforcementactivitiesbyfda

348

FDA Data Standards: An Update  

Center for Drug Evaluation (CDER)

Text Version... www.diahome.org Health Level 7 (HL7) • HL7 is the world's leading standards development organization for healthcare information exchange ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

349

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... identified using currently accepted clinical criteria (eg, ABO blood group incompatibility, glucose-6-phosphate dehydrogenase (G6PD) deficiency ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

350

FDA 1999 Food Code - Preface  

Center for Food Safety and Applied Nutrition (CFSAN)

... there are differences between the two models in the ... be helpful to the user such as model forms that ... for certain food processes for use in evaluating ... More results from www.fda.gov/food/guidanceregulation/retailfoodprotection

351

FDA Risk Communication Advisory Committee  

Center for Biologics Evaluation and Research (CBER)

Text Version... of Journalism and Mass Communication N107 Corverdell ... Health News Review Massachusetts General Hospital ... Fruit Street Boston, Mass, 02114 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

352

FDA Advisory Committee Briefing Document  

Center for Biologics Evaluation and Research (CBER)

Text Version... Ethnic Origin: n (%) Italian Unknown Egyptian Iranian Indonesian Thai Greek ... overload in subjects with transfusion dependent thalassemia in Iran ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

353

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... This proposal was based on pharmacokinetic data alone. The efficacy data (including both pain and fever) in this NDA consisted of ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

354

FDA Anti-Counterfeit Initiative  

Center for Drug Evaluation (CDER)

Text Version... Ability to capture EPC information upon shipment from our logistics centers ... with RFID and mass serialization throughout the distribution channel ... More results from www.fda.gov/downloads/drugs/drugsafety

355

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... Dose Finding and Efficacy Klaus Rabe, MD, Ph.D. Professor of Medicine, Department of Pulmonology Leiden University Medical Center Roflumilast ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

356

FDA Patient Safety Initiative Update  

Center for Drug Evaluation (CDER)

Text Version... Produce High quality data – Protect participants' rights, safety, and welfare ... Inability to verify critical efficacy and safety data ... More results from www.fda.gov/downloads/drugs/newsevents

357

FDA Safety and Innovation Act  

Center for Drug Evaluation (CDER)

Text Version... 22 Page 23. Performance commitments and fee ... Patient-focused drug development Enhancing Regulatory Science ... Enhanced Communication: ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

358

FDA and Cancer Vaccine Development  

Center for Biologics Evaluation and Research (CBER)

Text Version... lymphocytes… – Tissue engineered products, eg various ... Viral vectors and DNA vaccines ... Vector-based and DNA vaccines are attractive ... More results from www.fda.gov/downloads/biologicsbloodvaccines/newsevents

359

FDA 1997 Food Code - Preface  

Center for Food Safety and Applied Nutrition (CFSAN)

... In 1994, the Council for Agricultural Science and Technology estimated 6.5 ... government by providing them with a scientifically sound technical and ... More results from www.fda.gov/food/guidanceregulation/retailfoodprotection

360

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... strategies. The general consensus from the panel members they were unsure of how to translate animal data to humans. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

361

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... Kristine Khuc, Pharm.D. Dennis Ownby, MD Designated Federal Official, ... Call to Order at 8:00 am Dennis Ownby, MD Introduction of Committee ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

362

Reporting Surgical Fires to FDA  

Center for Drug Evaluation (CDER)

... Make and model of devices or drugs ... Device and Drug Manufacturers: Device manufacturers must comply with the Medical Device Reporting (MDR ... More results from www.fda.gov/drugs/drugsafety/safeuseinitiative

363

FDA Electronic Submissions Gateway (ESG)  

Center for Drug Evaluation (CDER)

Text Version... origin of submission as standard in order to implement ... How many people can share one account? Accounts in the ESG cannot be shared. ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

364

FDA's Risk Communication Advisory Committee  

Center for Biologics Evaluation and Research (CBER)

Text Version... Strategic Plan for Risk Communication and Transparency Task Force, discussion of foodborne outbreaks and related recall communications, and ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

365

FDA Patient Safety Initiative Update  

Center for Drug Evaluation (CDER)

Text Version... OSI assessment focused on reliability of data for key efficacy and safety parameters ... risks to quality; quality management ... Quality as a Culture ... More results from www.fda.gov/downloads/drugs/newsevents

366

FDA Risk Communication Advisory Committee  

Center for Biologics Evaluation and Research (CBER)

Text Version... I: In Section 3507 of the Patient Protection and Affordable Care Act, Congress told ... with drug manufacturers, clinicians, patients and consumers ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

367

Addendum to the FDA Backgrounder  

Center for Biologics Evaluation and Research (CBER)

Text Version... Age Ingested Substances Route & Reason ... Poison Control Centers Toxic Exposure Surveillance ... with dextromethorphan as an ingested substance More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

368

FDA OPHTHALMIC DEVICES ADVISORY PANEL ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... ACTIVITIES OF DAILY LIVING (ADL) RESULTS ... CHANGE FROM PREOPERATIVE IN ADL SCORES IMT-IMPLANTED EYES IMT-002 Page ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

369

FDA Critical Path Transporter Workshop  

Center for Drug Evaluation (CDER)

Text Version... Indiana U David Flockhart Steve Hall Page 8. 7 Shiew-Mei Huang ... Practice,” Ed. Waldman & Terzic, Elsevier (in press) Selected efflux & uptake ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

370

An Introduction to the FDA  

Center for Drug Evaluation (CDER)

Text Version... Despite MICU transfer, therapy with vancomycin and rifampin, and aggressive supportive care, the patient deteriorated and died 11 days after ... More results from www.fda.gov/downloads/drugs/drugsafety

371

FDA Backgrounder on Conjugated Estrogens  

Center for Drug Evaluation (CDER)

... Furthermore, based on the results of early studies, including studies of Premarin, the effects of estrogen on bone mineral density appeared to have ... More results from www.fda.gov/drugs/drugsafety/informationbydrugclass

372

FDA Announces Nutrition Roundtable Discussion  

Center for Food Safety and Applied Nutrition (CFSAN)

... The Roundtable format will consist of a panel of experts led by Stephen Sundlof, DVM, Ph.D., CFSAN Director, with remarks from David Acheson ... More results from www.fda.gov/food/newsevents/constituentupdates

373

Communications on FDA Pediatric Activities  

Center for Biologics Evaluation and Research (CBER)

Text Version... Pediatric Activities Judith Cope, MD, MPH - Safety ... Page 18. 18 Science: some other activities • Migraines in Pediatrics: why products do ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

374

FDA 1997 Food Code - Introduction  

Center for Food Safety and Applied Nutrition (CFSAN)

... the Lead Deputy Commissioner of the Food and Drug Administration, but in the strong support from the US Department of Agriculture's Food Safety ... More results from www.fda.gov/food/guidanceregulation/retailfoodprotection

375

FDA Approvals in Multiple Myelomar  

Center for Drug Evaluation (CDER)

Text Version... Page 13. 13 Choice of Endpoints – Response Rate or Time to Event? ... Page 14. 14 Choice of Endpoints – Response Rate or Time to Event? ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

376

Food and Drug Administration (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... risks, including the potential for abuse, of drugs containing hydrocodone ... Services received a request from the Drug Enforcement Administration for ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

377

FDA Advisory Committee Briefing Document  

Center for Biologics Evaluation and Research (CBER)

Text Version... the level of cortical tracer binding in the PET image and actual ?-amyloid levels measured post mortem by quantitative immunohistochemistry (IHC ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

378

www.fda.gov/spottheblock  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... Lily also has a total weakness for frozen sweets – and could use some help deciding whether to choose a frozen juice pop or ice cream! FOR ... More results from www.fda.gov/downloads/food/ingredientspackaginglabeling

379

Acrylamide, Furan, and the FDA  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... been pro- posed, including oxidation of polyunsat- urated fatty acids, breakdown of ascor- bic acid derivatives, breakdown of car- bohydrates, and ... More results from www.fda.gov/downloads/food/foodborneillnesscontaminants

380

FDA Electronic Submissions Gateway (ESG)  

Center for Drug Evaluation (CDER)

Text Version... the number of submissions held in the Web ... volunteers necessary to adequately test the service patch ... note – Axway has not tested their software for ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

381

FDA Industry Systems - System Status  

Center for Food Safety and Applied Nutrition (CFSAN)

... November 14, 2009: ESG Pre-Production (Test) system was unavailable from 6:00pm November 13, 2009 EST to 11:59pm November 14, 2009 EST ... More results from www.fda.gov/food/guidanceregulation/foodfacilityregistration

382

Acrylamide, Furan, and the FDA  

Center for Food Safety and Applied Nutrition (CFSAN)

Text VersionPage 1. IIn April 2002, Swedish scientists sur- prised the world by announcing the discovery of significant quantities of the ... More results from www.fda.gov/downloads/food/foodborneillnesscontaminants

383

FDA Electronic Submissions Gateway (ESG)  

Center for Drug Evaluation (CDER)

Text Version... For best optimization when processing and transmitting large multi-file submission files, first "tar" the files and then compress them using gzip. ... More results from www.fda.gov/downloads/drugs/newsevents

384

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... They considered the merits of an independent audit of investigator progression assessment in a pre- specified subgroup of patients instead of an ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

385

Questions and Answers About FDA's Enforcement Action ...  

Center for Drug Evaluation (CDER)

... While the FDA works to ensure that all marketed unapproved drugs obtain approval or are removed from the market, FDA provides various ... More results from www.fda.gov/drugs/guidancecomplianceregulatoryinformation/enforcementactivitiesbyfda

386

Testimony to the FDA Gastrointestinal Drug Advisory ...  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. Testimony to the FDA Circulatory System Devices Panel Regarding the CardioMEMS ... Page 6. FDA-Identified Limitations ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

387

Regulation of GE Animals at FDA  

Center for Biologics Evaluation and Research (CBER)

Text Version... Page 2. Regulation of GE Animals at FDA Larisa Rudenko, PhD, DABT ... Page 6. Regulation of GE Animals at FDA • FFDCA/NEPA • Guidance 187 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

388

FDA Expands Access to Investigational Drugs  

MedlinePLUS

... to Z Index Follow FDA FDA Voice Blog Enter Search terms Search the FDA Archive Home Food Drugs Medical ... is no longer maintained and may be outdated. Enter Search terms For Consumers Home For Consumers Consumer Updates Section ...

389

FDA Approves Therapy to Treat Gaucher Disease  

MedlinePLUS

... to Z Index Follow FDA FDA Voice Blog Enter Search terms Search the FDA Archive Home Food Drugs Medical ... is no longer maintained and may be outdated. Enter Search terms News & Events Home News & Events Newsroom Press Announcements ...

390

FDA's Regulatory Science Program in Nanotechnology  

Center for Biologics Evaluation and Research (CBER)

Text VersionFDA's Regulatory Science Program in Nanotechnology Science Board Update October 3, 2012 FDA Nanotechnology Task Force Page 2. ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

391

FDA Background for Colon Cancer Endpoints Workshop  

Center for Drug Evaluation (CDER)

Text VersionPage 1. FDA Background for Colon Cancer Endpoints Workshop ... I. FDA examination of endpoints for cancer drug approval ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

392

Dendritic Spines and Development: Towards a Unifying Model of Spinogenesis--A Present Day Review of Cajal's Histological Slides and Drawings  

PubMed Central

Dendritic spines receive the majority of excitatory connections in the central nervous system, and, thus, they are key structures in the regulation of neural activity. Hence, the cellular and molecular mechanisms underlying their generation and plasticity, both during development and in adulthood, are a matter of fundamental and practical interest. Indeed, a better understanding of these mechanisms should provide clues to the development of novel clinical therapies. Here, we present original results obtained from high-quality images of Cajal's histological preparations, stored at the Cajal Museum (Instituto Cajal, CSIC), obtained using extended focus imaging, three-dimensional reconstruction, and rendering. Based on the data available in the literature regarding the formation of dendritic spines during development and our results, we propose a unifying model for dendritic spine development.

Garcia-Lopez, Pablo; Garcia-Marin, Virginia; Freire, Miguel

2010-01-01

393

Telecytology: Distant Diagnosis and Quality Control with SMALL SIZE VIRTUAL SLIDE  

Microsoft Academic Search

Word Count: 224 ABSTRACT - OBJECTIVE: The study presents a novel collaborative system based on Small Size Virtual Slide (SSVS) technique and its suitability for telecytology diagnosis and quality control. SSVS is a low power acquisition system that digitises the whole slide and builds a virtual slide JPEG2000 10:1. Digital cytology slides of small size are reviewed through intranet or

F. Marcano; N. de Armas; A. Diaz-Cardama; O. Ferrer-Roca

2000-01-01

394

Fuzzy logic based sliding mode controlled dc-dc boost converter  

Microsoft Academic Search

This paper presents a modified design of a sliding mode controller based on fuzzy logic for a dc-dc boost converter. Here a proportional - integral (PI)-type current mode control is employed and a sliding mode controller is designed utilizing fuzzy algorithm. Sliding mode controller ensures robustness against all variations and fuzzy logic helps to reduce chattering phenomenon introduced by sliding

M. Shamim-Ul-Alam; M. Quamruzzaman; K. M. Rahman

2010-01-01

395

Position sensorless control for PMSM using sliding mode observer and phase-locked loop  

Microsoft Academic Search

In this paper, a novel sliding mode observer is presented for achieving the position sensorless vector control based on estimating the rotor position of permanent magnet synchronous machines. Compared to conventional sliding mode observer (SMO), the proposed observer based on sliding mode observer and phase-locked loop (PLL) can effectively reduce the influence of the sliding mode chattering and improve the

Ran Li; Guangzhou Zhao

2009-01-01

396

MOSFET Converter-Fed Position Servo System with Sliding Mode Control  

Microsoft Academic Search

Sliding mode control is an effective means to keep a system insensitive to parametric variations and disturbances. In the conventional sliding mode control applied to position servo systems, the sliding mode regime is restricted near the origin, and, therefore, insensitivity cannot be ensured throughout an entire response. This paper presents a new method in which a sliding curve is used

Fumio Harashima; Hideki Hashimoto; Seiji Kondo

1985-01-01

397

FDA Issues Information for Foreign Governments: Frequently ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... Constituent Updates. -. FDA Issues Information for Foreign Governments: Frequently Asked Questions on Systems Recognition. September 5, 2013. ... More results from www.fda.gov/food/newsevents/constituentupdates

398

FDA Drug Safety Podcast for Healthcare Professionals ...  

Center for Drug Evaluation (CDER)

... other psychiatric drugs with lesser degrees of serotonergic ... FDA Drug Safety Communication: Serious CNS reactions ... Office of Communications. ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

399

FDA Drug Safety Podcast for Healthcare Professionals ...  

Center for Drug Evaluation (CDER)

... FDA Drug Safety Podcast for Healthcare Professionals: Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine). ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

400

Regulatory Report: FDA's Food Contact Substance ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... Regulatory Report: FDA's Food Contact Substance Notification Program. Authors. ... Food Contact Substance Formulations. ... More results from www.fda.gov/food/ingredientspackaginglabeling/packagingfcs

401

FDA Issues Environmental Assessment Report Following ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... News & Events. Constituent Updates. -. FDA Issues Environmental Assessment Report Following Outbreaks Linked to Cantaloupe. March 1, 2013. ... More results from www.fda.gov/food/newsevents/constituentupdates

402

FDA Drug Safety Podcast for Healthcare Professionals ...  

Center for Drug Evaluation (CDER)

... of the FDA's Adverse Event Reporting System (AERS) database ... agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

403

FDA Announces Extension of Comment Period on ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... Constituent Updates. -. FDA Announces Extension of Comment Period on Conventional Foods Marketed As Functional Foods. January 5, 2007. ... More results from www.fda.gov/food/newsevents/constituentupdates

404

FDA Public Health Notification: Vista Cord, LLC  

Center for Biologics Evaluation and Research (CBER)

... Safety & Availability (Biologics). Tissue Safety & Availability. -. FDA Public Health Notification: Vista Cord, LLC. Date: September 25, 2009. ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/tissuesafety

405

FDA Safety Communication: New boxed warning for ...  

Center for Biologics Evaluation and Research (CBER)

... FDA Safety Communication: New boxed warning for thrombosis related to human immune globulin products. Date: June 10, 2013. ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability

406

Locking Lorentz slides  

Microsoft Academic Search

The purpose of this paper is to introduce the concept of a Locking Lorentz Slide. Lorentz Slide actuators, which are based on the Lorentz force principal of physics and are also called Voice Coils, have earned wide-spread use in the aerospace industry because of their superior performance (precision, force, stroke, wide temperature range including cryogenics, reliability and compactness). NASA has

John M. Vranish; Lawrence M. Germann; Donald R. Lutter; Dale A. Lawrence

1998-01-01

407

THE SLIDING PHASE VOCODER  

Microsoft Academic Search

The Sliding Discrete Fourier Transform (Sliding DFT) is used as the engine of a phase vocoder, to create a Slid- ing Phase Vocoder (SPV). With a little care this allows very accurate pitch shifting and low latency, and opens a number of possible extensions. We also consider the use of vector parallel processing to make these techniques a viable option.

Russell Bradford; Richard Dobson

408

Mini Lessons from FDA.  

ERIC Educational Resources Information Center

Eight self-contained lessons present information about topics of current interest in the Food and Drug Administration. Multidisciplinary in nature, the lessons can be integrated into ongoing activities in elementary or secondary level reading, math, language arts, social studies, science, art, health, consumer education, and home economics. The…

Food and Drug Administration (DHEW), Washington, DC.

409

FDA regulation of tobacco: blessing or curse for FDA professionals?  

PubMed

Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields. PMID:19999639

O'Reilly, James T

2009-01-01

410

FDA Transcript: FDA Actions Related to Nicotine Replacement ...  

Center for Drug Evaluation (CDER)

Text Version... 21 22 Today my goal is to share with others what ... tried in the past to make a change; and the results ... athlete into a competition with a pep talk like, ... More results from www.fda.gov/downloads/drugs/newsevents

411

Transcript - FDA Workshop on Behavior-Based Donor ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... If donors are ineligible based on behavioral risks, clinical or physical evidence or even reactive test ... the present practice and regulations in Europe. ... More results from www.fda.gov/downloads/biologicsbloodvaccines/newsevents

412

Science at FDA: Update for the Science Board  

Center for Biologics Evaluation and Research (CBER)

Text Version... Project 2a: Hyperspectral Imaging (HSI) – to be presented at SPIE 2013 Fabrication and characterization of phantoms made of ABS and PDMS ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

413

FDA Announces Final Rule on Administrative Detention of ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... food product only when it had credible evidence that a food product presented a threat of serious adverse health consequences or death to humans ... More results from www.fda.gov/food/newsevents/constituentupdates

414

FDA and FSIS to Convene Stakeholder Meeting on Food ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... human and animal food products and ingredients that are causing illness outbreaks or presenting other risks to the health of consumers or animals. ... More results from www.fda.gov/food/newsevents/constituentupdates

415

AASLD-FDA-NIH-PhRMA - Hepatotoxicity Special Interest ...  

Center for Drug Evaluation (CDER)

... Presentations; Guidance for Industry (Draft): Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 355KB) (posted 25 October 2007): ... More results from www.fda.gov/drugs/scienceresearch/researchareas

416

FDA Questions for Circulatory System Devices Panel October ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... presents the primary effectiveness results when the inadequate drug washout, late cardioversions, alternate methods of lesion creation, and current ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

417

FDA Food Code 2009: Annex 3 - Public Health Reasons ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... Nonetheless, the plan review step presents a unique opportunity to lay a foundation that enables the proposed operation to proactively sustain ... More results from www.fda.gov/food/guidanceregulation/retailfoodprotection

418

AASLD-FDA-NIH-PhRMA Hepatotoxicity Steering Group ...  

Center for Drug Evaluation (CDER)

... Presentations: Characterization of risk for drug-induced serious liver injury prompted by a series of spontaneously reported post-marketing cases. ... More results from www.fda.gov/drugs/scienceresearch/researchareas

419

FDA Science Looking Forward: Background and Initial Charge ...  

Center for Biologics Evaluation and Research (CBER)

... also present new needs and opportunities for regulatory science that are critical to their success. ... Area II: Extramural Programs and Collaborations. ... More results from www.fda.gov/advisorycommittees/committeesmeetingmaterials/scienceboardtothefoodanddrugadministration

420

Fatalities Reported to FDA Following Blood Collection and ...  

Center for Biologics Evaluation and Research (CBER)

... when donor ABO antibodies in the transfusion product are incompatible with the patient's red blood cells and are present in sufficiently high titers to ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/reportaproblem

421

Ornamental Landscape Grasses. Slide Script.  

ERIC Educational Resources Information Center

This slide script to accompany the slide series, Ornamental Landscape Grasses, contains photographs of the 167 slides and accompanying narrative text intended for use in the study and identification of commercially important ornamental grasses and grasslike plants. Narrative text is provided for slides of 62 different perennial and annual species…

Still, Steven M.; Adams, Denise W.

422

Quasistatic manipulation with compliance and sliding  

SciTech Connect

The authors propose a method for modeling dextrous manipulation with sliding fingers. The approach combines compliance and friction limit surfaces. The method is useful for describing how a grasp will behave in the presence of external forces (e.g., when and how the fingertips will slide) and for planning how to control the fingers so that the grasped object will follow a desired trajectory. The sliding trajectories are characterized by a transient and steady-state solution. The underlying theory is first discussed and illustrated with several single-finger examples. Experimental results are also presented. The analysis is then extended to grasps with multiple sliding and nonsliding fingers. The multifinger analysis is illustrated with an example of manipulating a card with two soft-contact fingers.

Kao, I. (San Jose State Univ., CA (United States)); Cutkosky, M.R. (Stanford Univ., CA (United States))

1992-02-01

423

FDA Errata to Background information  

Center for Biologics Evaluation and Research (CBER)

Text Version... 1 Page 3. Original: In subjects with mild (creatinine clearance 50 to < 80 mL/min), moderate (creatinine clearance 30 to < 50 mL/min) or severe renal ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

424

FOOD AND DRUG ADMINISTRATION (FDA)  

Center for Biologics Evaluation and Research (CBER)

Text Version... Speakers (Non-voting): Mark D. Challberg, Ph.D.; Inger K. Damon MD, Ph.D., FIDSA; Ali S. Khan MD, MPH; Gerald R. Kovacs, Ph.D.; Eric M. Mucker ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

425

MEDICATION ERRORS: AN FDA PERSPECTIVE  

Center for Drug Evaluation (CDER)

Text Version... “It ain't what you know that gets you in trouble, it's what you know for sure that ain't so.” -Mark Twain Page 8. PARIS IN THE THE SPRING ... More results from www.fda.gov/downloads/drugs/newsevents

426

FDA Almanac, Fiscal Year 1993.  

National Technical Information Service (NTIS)

FDA is responsible for ensuring that foods are safe, wholesome, and honestly labeled. It has always been among the agency's top priorities to ensure that medicines are safe and effective, and that new therapies are made available to patients as quickly as...

1993-01-01

427

FDA's perspectives on cardiovascular devices.  

PubMed

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial. PMID:20559979

Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G

2009-03-10

428

Paleo Slide Set: Coral Paleoclimatology  

NSDL National Science Digital Library

This slide show presents information about corals, which build carbonate skeletons over many years, forming the beautiful reefs common in tropical seas. Some coral species are sensitive to water temperatures and other environmental factors, and their skeletons can record information on past climate. This slide set discusses the future implications of climate variability through the use of color photos of undersea coral, coral drilling and an accompanying text. Also included are graphic representations that discuss high-resolution paleoclimatic proxy data from corals, El Nino-Southern Oscillation (ENSO) reconstructions and the Pacific Climate System. This set can be used as a comprehensive educational tool for studying current issues in marine ecology, global warming and ENSO. Each photograph can be enlarged for better viewing.

429

FDA Drug Safety Podcast: FDA warns of rare but serious skin ...  

Center for Drug Evaluation (CDER)

... FDA Drug Safety Podcast: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen. Listen to This Podcast. ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

430

No Slide Title  

Center for Biologics Evaluation and Research (CBER)

Text Version... members provided with household antibiotic kit (HAK), individual workplace antibiotic kit (IAK) ... household member – IAK -- 1 workplace bottle per ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

431

No Slide Title  

Center for Drug Evaluation (CDER)

Text Version... 1). Evidence of liver injury known or suspected to be related to consumption of a drug or CAM product in the past 6 months defined as: ... More results from www.fda.gov/downloads/drugs/scienceresearch

432

No Slide Title  

Center for Drug Evaluation (CDER)

Text Version... idiosyncratic hepatotoxins and either see what animal data showed or do new studies. ... drugs in SH depleted animals, a test that ... Has such testing ... More results from www.fda.gov/downloads/drugs/scienceresearch

433

Backup Slides Begin Here  

Center for Biologics Evaluation and Research (CBER)

Text Version... Page 9. Summary of ULTAMET Performance in UK and Australian National Joint Registries ... and Australian National Joint Registries ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

434

No Slide Title  

Center for Biologics Evaluation and Research (CBER)

Text Version... breast biopsy every 36 months Continuing Experience Continuing Education ... the procedure • Case material • Devices – Gun-needle – Vacuum ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

435

No Slide Title  

Center for Drug Evaluation (CDER)

Text Version... Trial design considerations – Randomized, blinded trials required to show an effect ... as an adjunct to surgery and radiation ... General Discussion ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

436

Guests Slides ODAC  

Center for Biologics Evaluation and Research (CBER)

Text Version... Rigorously define non-target progression ? Automate non-target progression (eg, texture?) ? Improve detection of new lesions (eg, CAD?) ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

437

No Slide Title  

Center for Drug Evaluation (CDER)

Text Version... I. Pre-clinical in vitro • Suggest metabolites react to inhibit P450, ... “lead to an immune response against P450, which causes hepatic necrosis.” Is this ... More results from www.fda.gov/downloads/drugs/scienceresearch

438

No Slide Title  

Center for Drug Evaluation (CDER)

Text VersionPage 1. 1 Statement of the Biotechnology Industry Organization ... Biotechnology Industry Organization (BIO) (202) 962 9239 sradcliffe@bio.org More results from www.fda.gov/downloads/drugs/drugsafety

439

Ped ODAC Slides  

Center for Biologics Evaluation and Research (CBER)

Text VersionSodium Thiosulfate (STS) for the Preven6on of Ototoxicity Induced by Pla6num Chemotherapy in ... 9 Page 10. Cispla n Ototoxicity Risk Factors ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

440

DODAC Meeting Slides  

Center for Biologics Evaluation and Research (CBER)

Text Version... Thickness map central subfield ... Deterioration Despite Repeated Lasers Right eye ... thickness >300 µ? after at least two previous laser treatments ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

441

SNM Slides Suleiman 2010  

Center for Drug Evaluation (CDER)

Text Version... (current) Page 19. 19 Anatomy in 2D Baseline 8 Weeks WHO: Bi-linear Measurement (1970's) RECIST: Linear Measurement (2000) Page 20. 20 ... More results from www.fda.gov/downloads/drugs/scienceresearch

442

No Slide Title  

Center for Drug Evaluation (CDER)

Text Version... THE THREAT OF DILI 1. Yellow Alert – significant increased incidence of ALT >3x ULN ... 2. Orange Alert – ALT >5, 10,20 xULN (more specific-? ... More results from www.fda.gov/downloads/drugs/scienceresearch

443

No Slide Title  

Center for Drug Evaluation (CDER)

Text VersionPage 1. 1 Evidence of Clinical Effectiveness and Data Requirements Eileen Navarro, MD, FACP Lead Medical Officer Division ... More results from www.fda.gov/downloads/drugs/developmentapprovalprocess

444

No Slide Title  

Center for Drug Evaluation (CDER)

Text Version... the acknowledged gold standard in chlorhexidine rinses Page 67. ... Peridex ? Claims suggests that: ? Peridex is the gold standard for chlorhexidine ... More results from www.fda.gov/downloads/drugs/newsevents

445

Slikker - NCTR Slides  

Center for Biologics Evaluation and Research (CBER)

Text Version... The NTP-IAG has had a large impact on study nominations and in providing the ... Maintain and enhance IAG support (eg, TSSRC) ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

446

Slide Show Template  

Center for Biologics Evaluation and Research (CBER)

Text Version... Basic protocol approach: – Search Strategy for identifying TEE: Medical Dictionary for Regulatory Activities ... After IVIG Infusion Unknown All 1 (1%) ... More results from www.fda.gov/downloads/biologicsbloodvaccines/newsevents

447

No Slide Title  

Center for Drug Evaluation (CDER)

Text Version... 5. Controls 6. Microbiology 6. Microbiology 7. Inspection ... 11. Bioavailability Page 34. Microbiology Assure the sterility of the product through the ... More results from www.fda.gov/downloads/drugs/newsevents

448

No Slide Title  

Center for Drug Evaluation (CDER)

Text Version... study linked to greater chance of 'capture' in health care networks Page 11. ... retrospectively with DILI in referring health care system ... More results from www.fda.gov/downloads/drugs/scienceresearch

449

No Slide Title  

Center for Drug Evaluation (CDER)

Text Version... DILI without ALF likely larger that those with ALF ? study linked to greater chance of 'capture' in health care networks Page 11. ... More results from www.fda.gov/downloads/drugs/scienceresearch

450

Small Business Kassim Slides  

Center for Drug Evaluation (CDER)

Text Version... can harm subjects Unlimited access compromises ... Controls such that data is accurate, legible, ... adequately controlled for study reconstruction 19 ... More results from www.fda.gov/downloads/drugs/newsevents

451

No Slide Title  

Center for Drug Evaluation (CDER)

Text Version... duodenum Kupffer Cell (Endothelial cell) Partial Hepatectomy or Liver Injury Portal Blood Flow LPS T3 Insulin Norepi nephrine EGF HGF TGF? IL-6 ... More results from www.fda.gov/downloads/drugs/scienceresearch

452

No Slide Title  

Center for Drug Evaluation (CDER)

Text Version... January 9, 2007 David Jacobson-Kram, Ph.D., DABT Office of New Drugs ... Determine whether it is safe to put drug candidate into humans ... More results from www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation

453

No Slide Title  

Center for Drug Evaluation (CDER)

Text Version... Page 18. Bone Marrow Derived Stem Cells Role for the nAChR in their mobilization Endothelial stem cell Page 19. Endothelial ... More results from www.fda.gov/downloads/drugs/newsevents

454

Small Business Slides  

Center for Drug Evaluation (CDER)

Text Version... development program, thus avoiding costly and time consuming attempts at correction later in the process Page 11. 10 EOP 2 Meeting (cont) ... More results from www.fda.gov/downloads/drugs/newsevents

455

ODAC Core SLides  

Center for Biologics Evaluation and Research (CBER)

Text Version... Explore alternative methods to evaluate bias ? Audits Page 13. 13 ... Should explore alternative methods to evaluate bias ? audits Page 18. 4 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

456

FDA relations during drug development.  

PubMed

Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pre-new drug application (pre-NDA) submission phases. Appropriate informal discussions via fax and telephone are also encouraged. By proactively interacting with the FDA, the pharmaceutical industry increases the probability of a successful drug development program. PMID:22034136

Mitchel, J T

2000-09-01

457

Sliding-Mode Tracking Control of Surface Vessels  

Microsoft Academic Search

A sliding-mode control law is presented and experimentally implemented for trajectory tracking of underactuated autonomous surface vessels. The control law is developed by introducing a first-order sliding surface in terms of surge tracking errors and a second-order surface in terms of lateral motion tracking errors. The resulting sliding-mode control law guarantees position tracking while the rotational motion remains bounded. The

Hashem Ashrafiuon; Kenneth R. Muske; Lucas C. McNinch; Reza A. Soltan

2008-01-01

458

Recruitment Tips: Slides  

NSDL National Science Digital Library

These are the slides for the webinar that was recorded 2/13/09. This presentation is a significantly refined repeat of a NetWorks webinar given in February of 2008 that was titled "Ten-Recruiting Tips - Thinking Outside the Box." While Technical Programs can use these tips, many of the tips will work for all different types of programs. Terry Bartelt, an instructor and former chair of the Electromechanical Program at Fox Valley Technical College, identifies proven recruitment and retention strategies that have enabled FVTC and other colleges to build and maintain high enrollments in technical programs. One segment of the presentation will be how to initiate small but meaningful strategic points of contact by faculty from a student's first college inquiry to his or her graduation. The other segment describes alternative program structuring to reach a larger student population.Despite the 60% decline in the enrollment of electronics technology programs over the past few years at community colleges across the United States, Fox Valley Technical College (FVTC) in Appleton, Wisconsin, has maintained strong enrollment numbers. Terry Bartelt, an instructor at FVTC, has more than 25 years experience in his field; his electromechanical technology program was recognized as one of the top ten programs in the country. Mr. Bartelt will present successful recruitment & retention practices, including effective and creative strategies for electronics, manufacturing, and other related technology programs. This is a high demand topic as he has spoken on this subject at several national conferences. Discover a multitude of proven recruitment tips to engage students and revitalize your programs.

2011-02-24

459

FDA Investigation Summary - Multistate Outbreak of ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... On April 24, 2013, the FDA placed Daniel Cardenas Izabal and Miracle Greenhouse on Import Alert. The Import Alert informs ... More results from www.fda.gov/food/recalls,%20outbreaks%20&%20emergencies/outbreaks

460

Consultation Procedures under FDA's 1992 Statement of ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... Consultation Procedures under FDA's 1992 Statement of Policy - Foods Derived from New Plant Varieties. June 1996; Revised October 1997. ... More results from www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation

461

FDA Food Safety Modernization Act (FSMA)  

Center for Food Safety and Applied Nutrition (CFSAN)

... the Oversight of Imported Foods FDA issues two proposed rules under aimed at strengthening assurances that imported food meets the same ... More results from www.fda.gov/food/guidanceregulation/fsma

462

FDA Public Health Advisory: Safety of Vioxx  

Center for Drug Evaluation (CDER)

... Based on this new safety information, Merck and FDA officials met the ... informed that Merck was voluntarily withdrawing Vioxx from the market place. ... More results from www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders

463

FDA BRIEFING DOCUMENT NDA 202293 DAPAGLIFLOZIN ...  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. FDA BRIEFING DOCUMENT NDA 202293 DAPAGLIFLOZIN TABLETS, 5 AND 10 MG SPONSOR: BRISTOL-MYERS SQUIBB ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

464

7-21-11 FDA GIDAC  

Center for Biologics Evaluation and Research (CBER)

Text Version... Uniformed Services of the United States Pediatric Gastroenterology and Nutrition ... Page 8. 8 FDA PARTICIPANTS (Non-Voting) 1 Mark Avigan, MD 2 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

465

FDA Drug Safety Communication: Updated information about ...  

Center for Drug Evaluation (CDER)

... is in follow-up to the FDA Drug Safety Communication posted on 7 ... in patients receiving other psychiatric drugs with lesser degrees of serotonergic ... More results from www.fda.gov/drugs/drugsafety

466

FDA Briefing Document NDA 200063 Contrave (Naltrexone ...  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. FDA Briefing Document NDA 200063 Contrave (Naltrexone 4mg, 8mg/Bupropion HCL 90mg extended release tablet) ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

467

Questions and Answers about FDA's Enforcement Action  

Center for Drug Evaluation (CDER)

Text Version... FDA has stated in a regulation since 1959 that drugs in this form ... by prescription only and are therefore covered by some health insurance plans. ... More results from www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation

468

FDA Foods and Veterinary Medicine Program THE ...  

Center for Food Safety and Applied Nutrition (CFSAN)

Text Version... For explanations of the commodity categories used in this report, please go to "Reportable Food Summary Report Definitions." FDA revised the 2nd ... More results from www.fda.gov/downloads/food/foodsafety

469

FDA ISSUES PUBLIC HEALTH WARNING ON ...  

Center for Drug Evaluation (CDER)

... FDA today issued a public health advisory concerning the risk of hemorrhagic stroke, or bleeding into the brain, associated with ... More results from www.fda.gov/drugs/drugsafety/informationbydrugclass

470

FDA Drug Safety Communication: Revised recommendations ...  

Center for Drug Evaluation (CDER)

... and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya ... More results from www.fda.gov/drugs/drugsafety

471

Agenda: FDA Actions Related to Nicotine Replacement ...  

Center for Drug Evaluation (CDER)

Text VersionFDA Actions Related to Nicotine Replacement Therapies and Smoking- Cessation Products; Report to Congress on Innovative Products and ... More results from www.fda.gov/downloads/drugs/newsevents

472

Questions and Answers About FDA's Enforcement Action ...  

Center for Drug Evaluation (CDER)

... The Notice is effective immediately, but FDA will exercise its enforcement discretion for a brief period before evaluating whether to take any further ... More results from www.fda.gov/drugs/guidancecomplianceregulatoryinformation/enforcementactivitiesbyfda

473

Errata to the FDA Briefing Document  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. Errata to the FDA Briefing Document Endocrinologic and Metabolic Drug Advisory Committee Meeting October 16, 2013 ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

474

FDA Video on Kids and Fiber Available  

Center for Food Safety and Applied Nutrition (CFSAN)

... on its website a new video for consumers on the importance of fiber in ... video, titled Kids 'n Fiber, features FDA nutrition expert, mother and dietitian ... More results from www.fda.gov/food/newsevents/constituentupdates

475

FDA Drug Safety Podcast for Healthcare Professsionals ...  

Center for Drug Evaluation (CDER)

... trial were later discussed at the FDA Endocrinologic and Metabolic Drugs Advisory ... was not shown to reduce coronary heart disease morbidity and ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

476

FDA Drug Safety Podcast for Healthcare Professionals ...  

Center for Drug Evaluation (CDER)

... FDA is aware of the results of controlled clinical trials that showed a higher rate of second primary malignancies among patients who were treated ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

477

FDA's role in responding to drug shortages  

Center for Drug Evaluation (CDER)

Text Version... The purpose of this article is to discuss FDA's role in re- solving drug ... Ev- ery attempt is made to avoid a short- age of medically necessary products. ... More results from www.fda.gov/downloads/drugs/drugsafety

478

FDA Confirms Salmonella on Sunrise Commodities' Turkish ...  

Center for Food Safety and Applied Nutrition (CFSAN)

Information on FDA's investigation into Salmonella on Sunrise Commodities' Turkish Pine Nuts. ... Salmonella Page on FoodSafety.gov. -. -. -. ... More results from www.fda.gov/food/recalls,%20outbreaks%20&%20emergencies/outbreaks

479

FDA Public Health Notification: Donor Referral Services  

Center for Biologics Evaluation and Research (CBER)

... regard to patient safety, where FDA had previously identified specific cases of concern, the firms cooperated fully in efforts to inform patients and ... More results from www.fda.gov/biologicsbloodvaccines/safetyavailability/tissuesafety

480

FDA Drug Safety Podcast for Healthcare Professionals ...  

Center for Drug Evaluation (CDER)

... Podcast for Healthcare Professionals: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

481

FDA Briefing Document Endocrinologic and Metabolic Drugs ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... Source: Response to FDA IR submitted 19 ... Taking Potent Antiretroviral Therapy: A Randomized ... trial's placebo group ingested far smaller volumes ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

482

FDA's Emergency Telephone Number Has Been Changed  

Center for Food Safety and Applied Nutrition (CFSAN)

... an FDA-regulated product, ie, foods, dietary supplements, cosmetics, human drugs, animal drugs, medical devices, biological products, and ... More results from www.fda.gov/food/newsevents/constituentupdates

483

FDA Rare Disease Patient Advocacy Day, 2012  

Center for Drug Evaluation (CDER)

... the banner of FDA–Rare Disease: Patient Advocacy ... coordinated by the Office of Orphan Drug Products ... to the needs of patients with rare diseases. ... More results from www.fda.gov/drugs/resourcesforyou/consumers

484

FDA Clinical Trial Requirements, Regulations, Compliance ...  

Center for Biologics Evaluation and Research (CBER)

... attendee should be able to: Discuss the Role of the FDA District Offices, how they are Structured and their Responsibilities; ... More results from www.fda.gov/biologicsbloodvaccines/newsevents/workshopsmeetingsconferences

485

FDA Drug Safety Podcast for Healthcare Professionals ...  

Center for Drug Evaluation (CDER)

... In non-emergency situations when non-urgent treatment with ... FDA Drug Safety Communication: Serious CNS reactions ... Office of Communications. ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

486

FDA Announces Dietetics and Nutrition Workshop  

Center for Food Safety and Applied Nutrition (CFSAN)

... The following is a tentative list of topics: Infant Formula, Medical Foods, Food Allergy, FDA Codex Alimentarius activities, Food Labeling Health ... More results from www.fda.gov/food/newsevents/constituentupdates

487

FDA Public Workshop Clinical Trial Design Issues ...  

Center for Drug Evaluation (CDER)

Text VersionPage 1. FDA Public Workshop Clinical Trial Design Issues – Development of New Therapies for Non-Muscle Invasive Bladder Cancer May 6, 2013 ... More results from www.fda.gov/downloads/drugs/newsevents

488

Questions and Answers: FDA announces new requirements ...  

Center for Drug Evaluation (CDER)

... addition, FDA responded to common questions about the new sunscreen regulations submitted by the WebMD community via Twitter and Facebook ... More results from www.fda.gov/drugs/resourcesforyou/consumers

489

FDA Foods Program Science and Research Steering ...  

Center for Biologics Evaluation and Research (CBER)

Text VersionPage 1. FDA Foods Program Science and Research Steering Committee (SRSC) ... Page 7. Foods and Veterinary Medicine Program Strategic Plan ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

490

FOOD AND DRUG ADMINISTRATION (FDA) CENTER FOR ...  

Center for Biologics Evaluation and Research (CBER)

Text Version... 21 22 1 FOOD AND DRUG ADMINISTRATION (FDA) ... Research Children's National Medical Center Washington, DC MARSHA D. RAPPLEY, MD ... More results from www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials

491

FDA Drug Safety Podcast for Healthcare Professionals ...  

Center for Drug Evaluation (CDER)

... Joan Powers, a Consumer Safety Officer in the Division, will provide you with ... will be re-evaluated periodically by FDA over the next ten years. ... More results from www.fda.gov/drugs/drugsafety/drugsafetypodcasts

492

Public Meeting: FDA Food Safety Modernization Act:  

Center for Food Safety and Applied Nutrition (CFSAN)

Text VersionPage 1. Public Meeting: FDA Food Safety Modernization Act: Focus on Inspections and Compliance Breakout Session: Discussion Questions ... More results from www.fda.gov/downloads/food/guidanceregulation

493

FDA's CORE: A Food Safety Network  

Center for Food Safety and Applied Nutrition (CFSAN)

... FDA) began operating CORE, the Coordinated Outbreak Response and Evaluation Network, in August 2011, it brought together a full-time team ... More results from www.fda.gov/food/recalls,%20outbreaks%20&%20emergencies/outbreaks

494

FDA Introduces New Twitter Feed on Foods  

Center for Food Safety and Applied Nutrition (CFSAN)

The US Food and Drug Administration (FDA) has introduced a new Twitter feed to aid in disseminating the agency's updates on food, nutrition, food ... More results from www.fda.gov/food/newsevents/constituentupdates

495

FDA Investigates Acute Hepatitis Illnesses Potentially Linked ...  

Center for Food Safety and Applied Nutrition (CFSAN)

... The FDA along with the Centers for Disease Control and Prevention (CDC) and the Hawaii Department of Health (DOH) are investigating a growing ... More results from www.fda.gov/food/recalls,%20outbreaks%20&%20emergencies/outbreaks

496

FDA Investigation Summary - Multistate Outbreak of ...  

Center for Food Safety and Applied Nutrition (CFSAN)

In August 2012, FDA warned consumers against eating mangoes from Agricola Daniella. Read details of the outbreak and the response to it. More results from www.fda.gov/food/recalls,%20outbreaks%20&%20emergencies/outbreaks

497

FDA Drug Safety Communication: Eosinophilic pneumonia ...  

Center for Drug Evaluation (CDER)

... Cubicin was prescribed for non-FDA approved indications, including osteomyelitis (n=4), prosthetic hip infection (n=1), enterococcal endocarditis ( ... More results from www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders

498

FDA Drug Safety Communication: Medication errors from ...  

Center for Drug Evaluation (CDER)

... Drugs. ... During FDA's evaluation of medication errors associated with Benadryl ... factors were identified as contributing to these medications errors: ... More results from www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders

499

Drug Safety Communication: FDA warns about potential ...  

Center for Drug Evaluation (CDER)

... Drug Administration (FDA) is alerting health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla ... More results from www.fda.gov/drugs/drugsafety

500

FDA Investigation Summary - Multistate Outbreak of ...  

Center for Food Safety and Applied Nutrition (CFSAN)

In August 2012, FDA warned consumers against eating mangoes from Agricola Daniella. Read details of the outbreak and the response to it. More results from www.fda.gov/food/recallsoutbreaksemergencies/outbreaks