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Regulatory Update
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21 May 2012
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Numerous regulatory agencies met on 18 May in Geneva, Switzerland to discuss whether it is possible to find new ways to allow their drug regulatory bodies to cooperate.The meeting, an international
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Regulatory Update
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21 May 2012
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A notice (Ordinance No. 748-B/2012) published by Anvisa on 18 May sets forth the criteria the agency will use for classifying materials as confidential and thus ineligible for release under the Access
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Regulatory Update
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21 May 2012
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Greater transparency is an integral part of the reorganization of Brazil’s national regulatory agency, Anvisa, and the agency will now release upon written request copies of all documents in its
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Regulatory Update
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18 May 2012
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On 17 May 2012, Yin Li, commissioner of the Chinese State Food and Drug Administration's (SFDA), signed a bilateral Memorandum of Understanding (MOU) with the Deputy Director of the Ukrainian State
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Regulatory Update
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17 May 2012
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The UK’s National Institute for Clinical Excellence (NICE) has issued a “final appraisal determination” recommending the use of abiraterone, in combination with glucocorticoids, for the second-line
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Regulatory Update
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17 May 2012
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The Chinese State Food and Drug Administration (SFDA) issued a Notice to Provinces, Autonomous Regions, and Municipalities on 16 May revising the instructions in the Chinese non-prescription drugs
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Regulatory Update
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14 May 2012
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Based on a 7 May agreement between Brazil’s National Health Surveillance Agency (ANVISA) and the Ministry of Agriculture, Livestock and Supply (MAPA), companies will be allowed to produce drugs for
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Regulatory Update
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14 May 2012
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Brazil and Argentina are drivers of regulatory harmonization regionally in South America, said Anvisa Chief Executive Dirceu Barbano, noting the countries’ efforts in the region.Both Brazil’s and
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Regulatory Update
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14 May 2012
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The Chief Executive of Brazilian regulatory authority Anvisa says the ongoing restructuring process at the agency is focused on the economic and social development of the country.The agency reforms
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Regulatory Update
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11 May 2012
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Despite the recognized life extending benefits of Sanofi’s new prostate cancer drug, Jevtana (cabazitaxel), the UK's National Institute for Health and Clinical Excellence (NICE) has recommended
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