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 In...
Ngày tải lên: 31/03/2014, 14:21
... With Acute Bacterial Versus Viral Rhinosinusitis? Recommendations 1. The following clinical presentations (any of 3) are recom- mended for identifying patients with acute bacterial vs viral rhinosinusitis: i. ... days posttreatment, and 92% for both groups at follow-up 1–2 weeks posttreatment (121 of 131 for doxcycline vs 129 of 140 for loracarbef). The microbio- logical eradi...
Ngày tải lên: 05/03/2014, 10:20
... commercials is for unhealthy foods. Thirty-one percent of the food commercials on popular African-American shows were for desserts or sweets 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 health professionals. J Sch Health 1999;69:290-291. Developing Strategies f...
Ngày tải lên: 07/03/2014, 08:20
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 a...
Ngày tải lên: 14/03/2014, 14:20
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 manage...
Ngày tải lên: 16/03/2014, 01:20
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 Indus...
Ngày tải lên: 18/03/2014, 00:20
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...
Ngày tải lên: 23/03/2014, 10:20
Guidance for Industry - How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1) potx
... divided manufacturing. GUIDANCE FOR INDUSTRY 1 How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1) I. INTRODUCTION This 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...
Ngày tải lên: 23/03/2014, 13:20
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 Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, ... information. The format of an NDA submission and the requirements for its various sections are set forth in part 314 and discussed in several CDER guidance documents. VI. IN...
Ngày tải lên: 30/03/2014, 06:20