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Class JN.* Behind the Curve: A Critique of NGO Activity with regards to the Safety Concerns of Biologics. J Biolaw Bus. 2007;10(4):33-36.

December 7, 2007
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Non-governmental organizations, or NGOs, play a role in engaging the safety of biological medicines. NGOs should reconsider their roles as safety watchdogs in order to promote positive change with respect to biological medicines. Behind the Curve: A Critique of NGO Activity with regards to the Safety Concerns of Biologics

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Roberts R. Counterfeit Biologics: A Personal Narrative. J Biolaw Bus. 2007;10(4):37-39.

December 7, 2007
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Counterfeit drugs are not something that happen to someone else. Real people are affected by fake drugs they buy in pharmacies. It is an experience that teaches us the importance of safety of the drug supply. I know, because I was a victim. This is my story.

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Generics Urged to Get Involved in Fight Against Counterfeiting

December 7, 2007
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While counterfeiting is believed mainly to affect brand drugmakers, the practice, as well as various anticounterfeiting measures, has implications for generic companies, an industry expert says. In the U.S., political discussion of the pharmaceutical industry is focused on drug safety and the cost of healthcare, but in Europe a current hot-button issue is counterfeit medicines, Greg Perry, director general of…

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New drug scare

December 7, 2007
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BEIJING – The medicine cabinet in the average U.S. home is filling with drugs made in China, and some experts say that could be a prescription for trouble. China's booming pharmaceutical industry has doubled exports to the United States in five years, undercutting competitors and making U.S. consumers reliant on the safety of Chinese factories and captive to any disruptions…

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SAFEDRUG.pdf

December 6, 2007

SAFEDRUG.pdf

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FDA proposes heavier fines for fake drug business

December 6, 2007
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The Food and Drug Administration (FDA) is set to impose much higher fines on manufacturers, sellers and importers of fake drugs. The proposed amendment to the Drug Act of BE 2510 is seeking to fine fakedrug manufacturers up to Bt5 million, and sellers and importers up to Bt2 million. "Convicted offenders are also liable to a jail term," FDA deputy…

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Guest opinion: Counterfeit drugs the most dangerous Chinese export

December 5, 2007
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Legislation is yet again pending that will open America's borders to imported prescription drugs. But if proponents of importation have their way, the American market could be flooded with dangerous copycat and counterfeit drugs produced in China, Indonesia and other countries with a poor record on consumer safety. With this in mind, it's worth asking: If we can't ensure safe…

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Fake Drugs Kill the Poor

December 4, 2007
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Most Nigerians administer their own malaria treatment. They know the symptoms and they know the time-tested remedy–chloroquine, purchased from a local pharmacy or street trader. Unfortunately, chloroquine's effectiveness has deteriorated over the years as the malaria parasite has mutated and gained resistance to the drug. Chloroquine now fails most of the time it is administered. The best new drugs work…

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Drug chief admits industry problems

December 4, 2007
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A senior State Food and Drug Administration official admitted yesterday that quality problems existed with some exported pharmaceutical products, while highlighting the need for international co-operation in regulating the global drugs industry. "China is a huge drug-producing country, and the total value of output could reach 500 billion [yuan] each year," administration deputy head Wu Zhen said. "Quite a large…

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Liang BA.* A Dose of Reality: Promoting Access to Pharmaceuticals. Wake Forest Intell Prop LJ. 2007 Dec 1;8:301-386

December 1, 2007
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Abstract. The U.S. uses and benefits substantially from prescription drugs. Pharmaceuticals save lives, relieve suffering, and promote the quality of life for those with access to them. However, access means both availability of the authentic drug and access at prices patients can afford. Unfortunately, current public policy does not effectively address either component. The result is the worst of all…

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