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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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9 May 2013
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Congressional legislators have nearly cleared a new piece of legislation that would reauthorize the US Food and Drug Administration (FDA) to collect and spend user fees to facilitate and expedite the
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9 May 2013
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The European Medicines Agency (EMA) has announced that it will, starting immediately, be instituting new changes meant to simplify the process by which fees for orphan medicine applications are paid
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9 May 2013
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What comes to mind when you think about federal agencies that affect healthcare product regulation? If you're like many, the first agency to come to mind is the US Food and Drug Administration (FDA),
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9 May 2013
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What is an investigation drug worth? In a philosophical sense, an investigational drug may be priceless to a patient facing the prospect of certain death, offering them additional time, reduced
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9 May 2013
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A new draft guidance document released by the US Food and Drug Administration (FDA) aims to clarify details regarding so-called "expanded access" to pharmaceutical therapies that are currently being
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9 May 2013
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US FDA Saving the Pharma Industry With Faster Drug Approvals (Reuters) House Panel Approves
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