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23 May 2013
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The US Food and Drug Administration (FDA) has sent a rare Untitled Letter to pharmaceutical manufacturer Shionogi for the alleged failure of the company to comply with the terms of the mandatory
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23 May 2013
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When the US Food and Drug Administration (FDA) wants to make a point, it often does so through a series of similar-sounding Warning Letters. Earlier this year, for example, the agency sent eight
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23 May 2013
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EU regulators with the European Medicines Agency (EMA) have announced the issuance of six recommendations stemming from a workshop they recently conducted regarding methods to reduce medication
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Regulatory Update
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23 May 2013
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The European Commission has released the names of the first members to sit on the panel of experts it established in 2012 to provide advice to Member States on ways to contain healthcare
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23 May 2013
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Three US legislators have moved to introduce legislation they say would accelerate US Food and Drug Administration (FDA) approvals while giving patients the option to obtain therapies outside of
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23 May 2013
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The European Medicines Agency (EMA) has announced that its eSubmission Gateway will become mandatory for all electronic common technical document (eCTD) submissions made to the agency through the
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23 May 2013
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The US Senate's Health, Education, Labor and Pensions (HELP) Committee has advanced two long-sought-after proposals that would overhaul the framework by which the US Food and Drug Administration (FDA)
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23 May 2013
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US FDA panel backs limited rollout of Merck's sleep drug suvorexant (Fierce) (The Pink Sheet)
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Latest News
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22 May 2013
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As any regulatory professional can attest, finding information on the US Food and Drug Administration's (FDA) website is difficult—really, really difficult, even.So difficult, in fact, that it has
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22 May 2013
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The US Food and Drug Administration (FDA) has released a new manual of policies and procedures (MAPP) for its internal drug regulatory staff regarding the creation and maintenance of its electronic
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