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22 May 2012
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US Health and Human Services Secretary Kathleen Sebelius and Mexico’s Secretary of Health Salomón Chertorivski jointly announced the launch of a new program aimed at increasing regulatory cooperation
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22 May 2012
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The Indian government is preparing to establish a new regulatory agency in charge of regulating biotechnology product research, transport, import, manufacture and use, reports The Economic Times.The
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22 May 2012
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The National Institute for Health and Clinical Excellence (NICE) is aggressively firing back at a study released which claimed the health technology assessment (HTA) body was taking an average of five
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22 May 2012
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Health Canada released new, consolidated guidance regarding how sponsors should conduct and analyze comparative bioavailability studies used to support applications for generic medications.The 22 May
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22 May 2012
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The Food and Drug Administration Safety and Innovation Act (FDASIA), the Senate’s iteration of a package of user fee legislation and other regulatory reforms, advanced in the Senate on 21 May, moving
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22 May 2012
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The European Medicines Agency (EMA) released a new question and answer guidance document on 22 May to assist sponsors with submitting their veterinary dossiers in an electronic format.The document,
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22 May 2012
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An article published in The Lancet Infectious Diseases says nearly one-third of anti-malarial drugs in foreign countries are of insufficient quality, failing measures of chemical composition, adequate
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22 May 2012
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A group of 15 states is calling on the US Department of Justice (DOJ) and the US Food and Drug Administration (FDA) to appeal a Judge’s decision in a lawsuit against both FDA and the states’ ability
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22 May 2012
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An advisory committee to the US Food and Drug Administration (FDA) gave US-based manufacturer Johnson & Johnson’s (J&J) blood thinner Xarelto (rixaroxaban), experimentally used to treat acute coronary
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21 May 2012
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The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling for program proposed by the US Food and Drug Administration (FDA) to be scaled back, saying the agency’s proposal to review
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