perspective for pushing financial opportunity gains over appropriate procedural practices when offering this particular new product. The second contributory factor is utilization of a legal loophole that the IUD did not require filing a New Drug Application (NDA) with the Food and Drug Administration (FDA) because it was classified under medical device instead of a drug, thus there was not any current jurisdiction available at that time. The company intentionally took advantage of this loophole and lack of
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Pharmacogenomics 1.Introduction: Genomics: The study of genes and their function. Genomics aims to understand the structure of the genome, including the mapping genes and sequencing the DNA. Genomics examines the molecular mechanisms and the interplay of genetic and environmental factors in disease. It is used to determine the entire DNA sequence of an organisms and a fine scale genetic mapping. The field also includes study of intra genomic phenomena such as Hetrosis
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It will be more effective for Cymbalta to have an additional indication of efficacy in treating pain than once-a-day dosing for Major Depressive Disorder (MDD). There are many drugs available on the market claiming to treat depression, which have already been proven effective. However, there are currently no drugs on the market that can treat chronic pain in addition to depression. Thus, it would be to the advantage of Eli Lilly to strategically pursue clinical studies of Cymbalta for the pain indication
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Spring 2012 CITY OF NORTHFIELD RFP RESPONSE Contents Company Profile .............................................................................................................................. 2 Company name:....................................................................................................................... 2 Single point of contact name:.................................................................................................. 2 Total number of employees:
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September 2005 Project Portfolio Management at XYZ Pharma Early morning, Monday 29th August 2005. John Smith, head of portfolio management and strategic planning, was paging through the slides he had prepared for the Portfolio Management Board (PMB) meeting which would start at 9 am, and which was scheduled to last until Friday. “We have been preparing this meeting for weeks”, he thought, “and it seems the PMB has some tough decisions to make”. The PMB of XYZ Pharma, the pharmaceutical division
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September 2005 Project Portfolio Management at XYZ Pharma Early morning, Monday 29th August 2005. John Smith, head of portfolio management and strategic planning, was paging through the slides he had prepared for the Portfolio Management Board (PMB) meeting which would start at 9 am, and which was scheduled to last until Friday. “We have been preparing this meeting for weeks”, he thought, “and it seems the PMB has some tough decisions to make”. The PMB of XYZ Pharma, the pharmaceutical
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Risk Factor Analysis— A New Qualitative Risk Management Tool John P. Kindinger, Probabilistic Risk and Hazards Analysis Group, Los Alamos National Laboratory John L. Darby, Probabilistic Risk and Hazards Analysis Group, Los Alamos National Laboratory Introduction Project risk analysis, like all risk analyses, must be implemented using a graded approach; that is, the scope and approach of the analysis must be crafted to fit the needs of the project based on the project size, the data availability
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Top Questions from Union Budget 2015-16 Union Finance Minister Arun Jaitley presented the Union Budget for 2015-16 on 28 February 2015. This was the first full budget of the NDA government led by Prime Minister Narendra Modi. Following are the important questions coming out of the proposals coming out of this Budget. [pic] 1) What is the name of the proposed micro and SME development finance unit that was announced in the Budget? – MUDRA Bank [pic] 2) How much allocation has been made for the
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Chapter 1 Relevance, predictive value, faithful representation, completeness, neutrality, free from material errors Comparability, verifiability, timeliness, understandability Accrual, going concern and will continue in operation for the foreseeable future, materiality, conservatism principle Fair representation, must comply unless departure results in more faithful representation, going concern is used unless the management is aware otherwise (in which case disclosure is required) Current
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Indian Medical Device Industry Regulatory, Legal and Tax Overview March 2015 © Copyright 2015 Nishith Desai Associates www.nishithdesai.com The Indian Medical Device Industry Regulatory, Legal and Tax Overview About NDA Nishith Desai Associates (NDA) is a research based international law firm with offices in Mumbai, Bangalore, Silicon Valley, Singapore, New Delhi, Munich. We specialize in strategic legal, regulatory and tax advice coupled with industry expertise in an integrated
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