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13 May 2013
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The US Food and Drug Administration (FDA) has announced that it plans to move forward with a proposed study on direct-to-consumer (DTC) advertising first announced in August 2012 regarding the use of
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13 May 2013
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In a surprising move, the US Food and Drug Administration (FDA) on 10 May 2013 announced that it would permit generic competition to Endo Pharmaceuticals' generic pain pill Opana ER (oxymorphone
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13 May 2013
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US Did FDA Make a Huge Blunder Approving Merck’s Liptruzet? (MPT) (Forbes) (Pharmalot) (Counter:
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10 May 2013
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Hello and welcome to a new edition of Five in Focus, our Friday recap of the five most important, interesting, riveting or ground-breaking stories of the week.FDA Reaches out to Industry for Help as
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10 May 2013
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The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's chronic obstructive pulmonary disorder (COPD) drug Breo Ellipta (fluticasone furoate and vilanterol inhalation powder), just
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10 May 2013
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In a scathing ruling issued on 10 May 2013, US District Court Judge Edward Korman has ordered the US Food and Drug Administration (FDA) to approve Teva Women's Health's citizen petition to approve its
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10 May 2013
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When it comes to pharmaceutical compounding, the US Food and Drug Administration (FDA) knows it has a significant problem on its hands. But as Janet Woodcock, director of the Center for Drug
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10 May 2013
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The US Food and Drug Administration (FDA) has released a final guidance document that it says is intended to expedite the donation of blood and plasma for frequent donors.BackgroundThe final guidance,
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10 May 2013
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US FDA Begins Gearing up to Hire Huge Number of New Employees to Meet GDUFA Targets (FDA) J&J
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9 May 2013
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The US Food and Drug Administration (FDA) often finds itself in the firing line of US legislators. The reasons vary—unsafe drugs, a deficient supply chain, too much regulatory activity, too little
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