Latest News
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19 June 2013
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If you've been paying close attention to the US Food and Drug Administration's (FDA) emails over the last several weeks, you've likely caught onto something unusual: the agency's promotion of
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Regulatory Update
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19 June 2013
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Australia’s Therapeutic Goods Administration (TGA) opened a consultation on 18 June 2013 on the implementation of a 12-month trial period of an Over-the-Counter (OTC) New Product N2 application (or
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Regulatory Update
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19 June 2013
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Australia’s Therapeutic Goods Administration has launched a new Database of Adverse Event Notifications (DAEN), an online resource that will provide the public and the health care community with
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Latest News
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19 June 2013
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When the US Food and Drug Administration (FDA) approved a new four-strain flu vaccine manufactured by French life sciences manufacturer Sanofi in early June 2013, it didn't just mark a momentous
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Latest News
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19 June 2013
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The US Food and Drug Administration (FDA) has released a new guidance for industry that pertains to stability testing recommendations for generic drug products submitted under 505(j) of the Federal
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Latest News
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19 June 2013
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When US legislators and President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in July 2012, they did so – among other reasons – in the hope that
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Latest News
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19 June 2013
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US UDI Rule Due out Next Week: FDA Source (MDDI) After two deaths, FDA investigates Lilly
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Latest News
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18 June 2013
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In 2011, the director of the National Institutes of Health (NIH) reorganized several of his agency's departments into a new center, one intended to upend how pharmaceutical products reach the market
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Latest News
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18 June 2013
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The US Food and Drug Administration (FDA) this week released two new guidance documents regarding the regulatory considerations for minimally manipulated, unrelated allogeneic placental and umbilical
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Latest News
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18 June 2013
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The US Food and Drug Administration (FDA) has found itself mired in – quite literally – a crappy situation. In February 2013, the agency announced that it would reach out to the public in an attempt
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