oecd.org/document/24/0,3343,en_2649_34537_1885208_1_1_1_1,00.html
http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm134444.htm
http://usbiotechreg.nbii.gov / http://www.library.ca.gov/crb/96/07/BIOT_CH3.html
http://www.aphis.usda.gov/biotechnology/regulations.shtml http://docs.google.com/gview?a=v&q=cache:vSCxcd1d4t4J:leda.law.harvard.edu/leda/data/257/Stepp,_David_00.pdf+FDA+Biotechnology+regulation&hl=en&gl=us&pid=bl&srcid=ADGEEShg7mZQvgLsSrc0U0EQpfVJH107qeBzj3qcT3P87oSDcKqvFIAHT-Bryh3exK_5o56u0t9LDeh_S68n6zQaVeexCFI0wH8upPeBJp6hFWC83H5V7Axv8DF6KCP-FojIJwR5PkDz&sig=AFQjCNG00vPJgRaoWo4rtkY7LI7lpAIsqg
http://esciencenews.com/articles/2009/02/18/extensive.publication.bias.phase.i.drug.trials http://clinicaltrials.gov/ct2/info/understand http://www.bmj.com/cgi/content/extract/315/7106/480
http://www.antigenics.com/trials/about/
This situation illustrates the difficulties in navigating an uncertain regulatory environment. 3. It is reasonable that the WHO guidelines are used as the framework for U.S. policy. The U.S. system, however, is unique in certain ways. You alluded to the need to encourage innovation. The balance between innovation and cost control is different in the U.S. than in Europe, so I think that is why U.S. policy will look slightly
Corn pollen had a high mortality rate (44% in 4 days) compared to those fed on and regular corn pollen showing no mortality. [Frontline/Nova] The allergenic potential of the transgenes that are used in GM products is a frightening problem. A noticeable case is that of Pioneer Hi-Bred INC, the international seed company that produced a genetically modified and enriched Soybean using the Brazilian nut gene. Fortunately, before the product
Other avenues include television, newspapers and magazines, radio, web pages, and people to people exchange. Effective communication should be built on an understanding of the nature of consumer concerns. Information on biotechnology modifications should include the reasons for modification, degree of regulatory oversight, methods and extent of safety verification, and impact of modification on consumer safety and the environment." (Bruhn, nd) According to a report from the Food Policy
1). Prior to market introduction of a GMO for commercial use in any part of the EU, notification must be sent to the competent member state authority where the GMO will be released (Council Directive 90/220/EEC, art. 11 (1)). Notification must include a risk assessment with information necessary for evaluating the foreseeable risks posed by the GMO to human health or the environment, to which the competent authority will
Pharmaceutical industries have to operate in an environment that is highly competitive and subject to a wide variety of internal and external constraints. In recent times, there has been an increasing trend to reduce the cost of operation while competing with other companies that manufacture products that treat similar afflictions and ailments. The complexities in drug research and development and regulations have created an industry that is subject to intense
This can contribute directly to human health and development (AgBio). Borlaug (1999), who won the Nobel Prize in 1970 for his work in developing high-yield wheat and other grains in third-world countries, stresses that genetic engineering is essential due to the worldwide population growth. Other organizations supporting genetically modified foods are the American Medical Association, the International Association of African Scientists, the Organization for Economic Cooperation and Development, and
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