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Adverse event
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#	Item
951	CONFIDENTIAL “Safety Reporting Requirements for Human Drug and Biological Products” (TOME) Eli Lilly and Company has reviewed the titled draft regulation and is submitting the following comments, questions and recom Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-10-28 17:03:35 Health Food and Drug Administration Clinical research Pharmaceutical industry Drug safety MedDRA Adverse event Vaccine Adverse Event Reporting System MedWatch Pharmacology Pharmaceutical sciences Medicine
952	Baxter Healthcare Comments to the Proposed Safety Reporting Requirements for Human Drug and Biological Products: Proposed Rules October 14, 2003 Section FR Page Number Comment[removed]c)(2)(v)(C) (vi) & (vii) 12474 The r Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-10-28 17:03:40 Clinical research Research Pharmaceutical industry Clinical pharmacology United States Public Health Service MedDRA MedWatch Adverse event Adverse Event Reporting System Pharmacology Pharmaceutical sciences Food and Drug Administration
953	Letter of Amendment # 1 to: HPTN 052: A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy plus HIV Primary Care versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 In Serodisc Add to Reading List Source URL: www.hptn.org Language: English - Date: 2005-08-16 11:08:58 Pharmacology Scientific method Drug safety Design of experiments HPTN 052 Science Adverse event Institutional review board Clinical research Research Pharmaceutical industry
954	About AAMI The Association for the Advancement of Medical Instrumentation (AAMI), a nonprofit organization founded in 1967, is a diverse alliance of more than 6,000 members from around the world united by one critical m Add to Reading List Source URL: www.aami.org Language: English - Date: 2012-04-23 02:19:29 Infusion pump Patient safety organization Medical device Food and Drug Administration Patient safety Biomedical engineering Adverse event Association for the Advancement of Medical Instrumentation Medicine Health Medical equipment
955	This graph depicts what happens to an adverse event report that is submitted to FDA. First, FDA may receive one of two types of reports: mandatory or voluntary. A mandatory report is sent to FDA by a manufacturer, import Add to Reading List Source URL: www.fda.gov. Language: English Food and Drug Administration Clinical research Pharmaceutical industry Therapeutics Adverse event Adverse Event Reporting System Unique Device Identification Pharmaceutical sciences Pharmacology Research
956	MONITORING ERROR IN THE MEDICAL LABORATORY A REVIEW OF THE BC PATIENT SAFETY AND LEARNING REPORTING SYSTEM VERONICA RESTELLI Laboratory Error Add to Reading List Source URL: www.polqm.ca Language: English - Date: 2012-05-04 18:31:51 Medical terms Medical ethics Hospice Nursing Medical error Near miss Adverse event Patient safety organization Medicine Health Patient safety
957	November 7, 2012 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm[removed]Rockville, MD[removed]Re: [Docket No. FDA-2011-N[removed]Comments on the Proposed Rule, “Unique Device Add to Reading List Source URL: npalliance.org Language: English - Date: 2012-11-08 18:07:25 Pharmaceutical sciences Unique Device Identification Medical device MedWatch Adverse Event Reporting System Electronic health record Global Harmonization Task Force Clinical trial Food and Drug Administration Medicine Health
958	Microsoft Word - EM00543-02 Add to Reading List Source URL: www.radiesse.com Language: English - Date: 2014-01-08 12:35:13 Prosthetics Breast implant Breast surgery Adverse event ArteFill Medicine Surgery Implants
959	Package ‘HH’ September 13, 2014 Type Package Title Statistical Analysis and Data Display: Heiberger and Holland Version[removed]Date[removed] Add to Reading List Source URL: cran.r-project.org Language: English - Date: 2014-09-13 02:34:15 Biostatistics Relative risk Adverse event Plot Science Epidemiology Statistics Medical statistics
960	Genomics anc Population Health 2005 Add to Reading List Source URL: www.cdc.gov Language: English - Date: 2009-06-23 14:36:44 Prevention Drug safety Centers for Disease Control and Prevention Public safety Vaccine Safety Datalink Vaccine Adverse Event Reporting System Vaccine Hepatitis B vaccine Smallpox vaccine Vaccines Medicine Vaccination

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