Guidance for Industry Acute Bacterial Sinusitis: Developing Drugs for Treatment ppt

... http://www.fda.gov /Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 16 Guidance for Industry Acute Bacterial Sinusitis: Developing Drugs for Treatment ... the relevant bacterial pathogens).” 17 Guidance for Industry Acute Bacterial Sinusitis: Developing Drugs for Treatment Additional ... Contains Nonbinding Recommendations Guidance for Industry 1 Acute Bacterial Sinusitis: Developing Drugs for Treatment This guidance represents the Food and Drug Administration’s...

IDSA Clinical Practice Guideline for Acute Bacterial Rhinosinusitis in Children and Adults pot

... With Acute Bacterial Versus Viral Rhinosinusitis?Recommendations1. The following clinical presentations (any of 3) are recom-mended for identifying patients with acute bacterial vs viralrhinosinusitis:i. ... days posttreatment, and 92% for bothgroups at follow-up 1–2 weeks posttreatment (121 of 131 for doxcycline vs 129 of 140 for loracarbef). The microbio-logical eradication rate posttreatment ... focused exclusively on acute maxillary sinus-itis with little information on patients with involvement ofTable 11. Long Versus Short Courses of Antimicrobial Therapy for Acute Bacterial Rhinosinusitis...

FOOD AND BEVERAGE INDUSTRY MARKETING PRACTICES AIMED AT CHILDREN: DEVELOPING STRATEGIES FOR PREVENTING OBESITY AND DIABETES pdf

... commercials is for unhealthy foods. Thirty-onepercent of the food commercials on popular African-American shows were for desserts orsweets and 13 percent were for soda. In contrast, on shows for general ... 1993;148:151+.Levine J. Food industry marketing in elementary schools: implications for school healthprofessionals. J Sch Health 1999;69:290-291. Developing Strategies for Preventing Obesity 26McNeal ... Cross of CaliforniaThe California Endowment21650 Oxnard StreetSuite 1200Woodland Hills, CA 91367800.449.4149CM/PA Obesity and Diabetes 02/04 www.calendow.org Developing Strategies for Preventing...

HIV/AIDS Prevention Guidance for Reproductive Health Professionals in Developing-Country Settings doc

... come in.”4 For information on counseling people who attend antenatal clinics, see WHO 2000b. For information regard-ing reporting and partner notification guidelines, see WHO 1999b. For a general ... Women:Health Research Priorities for Women in Developing Countries. Washington, DC:ICRW.Leslie, J. and G. Rao Gupta. 1989.Utilization of Formal Services for Maternal Nutrition and Health ... BecauseHIV/AIDS information and services are pro-vided primarily in these settings, men aretherefore less likely to benefit from them andtherefore less likely to be fully informedabout HIV/AIDS...

Interpretive Guidance for Project Manager Positions - Including Guidance for Classifying, Staffing, Training, and Developing IT Project Managers docx

... Interpretive Guidance for Project Manager Positions CG03-0001 August 2003 U.S. Office of Personnel Management 1 Interpretive Guidance for Project Manager Positions Including Guidance for Classifying, ... processes. • Information Management - Identifies a need for and knows where or how to gather information; organizes and maintains information or information management systems. • Information Resources ... standards for making meaningful comparisons: • The JFS for Administrative Work in the Information Technology Group, GS-2200, to evaluate project manager positions for IT projects; • The JFS for...

Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance pdf

... the Agency the most appropriate option for their situation. FDA guidance for industry, Comparability Protocols – Chemistry, Manufacturing, and Controls Information, issued February 2003. Once ... B. Literature For additional information, refer to FDA's PAT Web page at http://www.fda.gov/cder/OPS/PAT.htm. 16 Guidance for Industry PAT ... (CDER) Center for Veterinary Medicine (CVM) Office of Regulatory Affairs (ORA) Pharmaceutical CGMPs September 2004 Guidance for Industry PAT — A Framework for Innovative...

Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration pptx

... regulations for biological products can be found at our website at www.fda.gov/opacom/laws. V. Whom Do You Contact For More Information? For more information about how we regulate drugs, devices, ... druginfo@cder.fda.gov. Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration DRAFT GUIDANCE This guidance document ... Center for Food Safety and Applied Nutrition, Food And Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740-3835. 301-436-1200 For human drugs, the Division of Drug Information...

Guidance for Industry - How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1) potx

... dividedmanufacturing. GUIDANCE FOR INDUSTRY 1How to Complete the Vaccine Adverse Event Reporting SystemForm (VAERS-1)I. INTRODUCTIONThis guidance for industry has been developed to clarify what information ... administered for some of the information (such as manufacturer, lot number or laboratory data.) Refer to the Reportable Events Table (RET) for events mandated for reporting by law. Reporting for other ... vaccination (specify)DIRECTIONS FOR COMPLETING FORM(Additional pages may be attached if more space is needed)GENERAL Use a separate form for each patient. Complete the form to the best of your abilities....

Guidance for Industry Botanical Drug Products docx

... grounds for a clinical hold are set forth in § 312.42(b)and discussed in CDER′s guidance for industry on Content and Format of InvestigationalNew Drug Applications (INDs) for Phase 1 Studies of Drugs, ... information. The formatof an NDA submission and the requirements for its various sections are set forth in part 314 anddiscussed in several CDER guidance documents.VI. INDS FOR BOTANICAL DRUGS If ... information on Guidance for Industry Botanical Drug ProductsCopies of this Guidance are available from:Division of Drug Information (HFD-240),Office of Training and Communications,Center for...

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