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ARTICLE 29 LAYOFF AND RECALL

Ohio 6/18/2008 | 0 (0) | 16 | 0 | 0 | English

ARTICLE 29 - LAYOFF AND RECALLThe language in this Article continues unchanged from the previous Agreement.29.01 Notice When the agency determines that a layoff is necessary, the agency shall  ... more>>

Medicis Announces Voluntary Recall of Solodyn

MissPowerPoint 5/21/2008 | 0 (0) | 20 | 0 | 0 | English

Medicis Announces Voluntary Recall of Solodyn?? (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-UpContact: Stericycle Customer Service  ... more>>

AASLD FDA NIH PhRMA January Session III Attribution Presentations

FDADocs 5/12/2008 | 0 (0) | 30 | 0 | 0 | English

AASLD- FDA-NIH-PhRMA January 25-26, 2006 Session III: Attribution of Causality (Moderator: Leonard Seeff; Reporters: Robert Fontana and David Lilienfeld)L. Seeff- Problems of Establishing Causality  ... more>>

AASLD FDA NIH PhRMA Hepatotoxicity Special Interest Group Meeting Agenda

FDADocs 5/12/2008 | 0 (0) | 27 | 0 | 0 | English

AASLD-FDA-NIH-PhRMA*- Hepatotoxicity Special Interest Group Meeting Brookside Gardens Conference...; meeting plans John Senior (FDA) Lana Pauls (FDA)Session I: FDA Concept Paper: Premarketing  ... more>>

AASLD FDA NIH PhRMA January Session I Non Presentations

FDADocs 5/12/2008 | 0 (0) | 20 | 0 | 0 | English

AASLD- FDA-NIH-PhRMA January 25-26, 2006 Session I: Non-Clinical Prediction (Moderator: Patrick Weir; Reporters: Frank Sistare and John Strong) P. Wier ??? Integrating Liver Toxicogenomics with  ... more>>

FDA Actions on New Bioterrorism Legislation

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

Center for Food Safety and Applied NutritionJanuary 2003 PROTECTING THE FOOD SUPPLY:FDA Actions on New Bioterrorism Legislation On June 12 President George W. Bush signed into law the Public  ... more>>

Hospital Acquired Pneumonia HAP IDSA PhRma FDA Working Group Meeting

FDADocs 5/12/2008 | 0 (0) | 36 | 1 | 0 | English

Hospital Acquired Pneumonia (HAP) Joint FDA/IDSA/PhRMA WorkshopSary Beidas, MD Medical Officer CDER/DSPIDPNovember 20, 2002Definition of HAP (& Diagnosis):???Clinical: Temp, WBC, Sputum  ... more>>

Clinical Trials in AECB IDSA PhRma FDA Working Group Meeting

FDADocs 5/12/2008 | 0 (0) | 28 | 0 | 0 | English

Clinical Trials in AECB FDA - IDSA - PhRMA WorkshopRoger M. Echols, M.D. Clinical Development - Infectious Diseases Bristol-Myers Squibb November 20, 2002AECB: Current Study Design  ... more>>

Antimicrobial Drug Development for Acute Bacterial Meningitis IDSA PhRma FDA Working Group Meeting

FDADocs 5/12/2008 | 0 (0) | 40 | 1 | 0 | English

Antimicrobial Drug Development for Acute Bacterial MeningitisJoint FDA/IDSA/PhRMA WorkshopImo Ibia, MD, MPH Medical Officer FDA/CDER/DSPIDPNovember 20, 2002Office of New Drugs IV Center  ... more>>

Drug Development for Resistant Pathogens IDSA PhRma FDA Working Group Meeting

FDADocs 5/12/2008 | 0 (0) | 18 | 0 | 0 | English

Drug Development for Resistant Pathogens-PhRMA Antibiotics Working GroupFrancis P. Tally MD Cubist Pharmaceuticals, Inc. November 19, 2002Antimicrobial Resistance in Nosoc...  ... more>>

FDA experience and perspective on non inferiority trials Presentations

FDADocs 5/12/2008 | 0 (0) | 40 | 0 | 0 | English

FDA Experience and Perspective on Non-Inferiority TrialsRobert J. Temple, M.D. Associate Director for Medical Policy Center for Drug Evaluation and Research U.S. Food and Drug AdministrationFDA  ... more>>

Issues and Controversies in DILI Session I FDA January 24 25 2007

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

Issues??and??Controversies??in??DILI?? Session??I:????FDA??Concept??Paper???????Premarketing...?? UNC?? GSK?? FDA?? FDA?? PhRMA??Session??1.1?? Drafting??of??Concept??Paper:????Premarketing  ... more>>

FDA Review of Investigational Cell Based Therapies Resource Tools Framework and Issues

FDADocs 5/12/2008 | 0 (0) | 18 | 0 | 0 | English

://www.fda.gov/cber/guidelines.htm. For questions on the content of this guidance, contact the  ... more>>


   
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