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14 May 2013
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US regulators of medical devices, and indeed all regulators, must balance two competing needs when it comes to regulation: the desire for a process to be as simple as possible, and the desire for a
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Regulatory Update
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14 May 2013
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Australia's Therapeutic Goods Administration (TGA) has opened a consultation to seek views from interested parties on the value, feasibility, design and impacts of a proposed new-to-market risk
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14 May 2013
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The National Association of Attorneys General, an organization comprised of all state attorneys general, has sent a letter to US Food and Drug Administration (FDA) Commissioner Margaret Hamburg asking
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14 May 2013
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The Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S), an international forum for the exchange of regulatory information about pharmaceutical products, may soon see itself with two
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14 May 2013
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Republican legislators on the House Energy and Commerce Committee announced on 13 May 2013 that they are opening an investigation into the unusual and unexpected departure of one of the US Food and
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14 May 2013
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US US Government Files Morning-After Pill Appeal (AP) (WSJ) (CBS) (The Hill) (SCOTUS Blog)
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13 May 2013
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As anyone who has ever lost power—be it because of a storm or a blown transformer—can attest, ours is a society that relies heavily on the use of electricity. Everything from our houses to our modes
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13 May 2013
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The US Department of Justice (DOJ) has announced that Indian generic pharmaceutical manufacturer Ranbaxy has pleaded guilty to three felony charges, including lying to the US Food and Drug
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Regulatory Update
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13 May 2013
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The Committee on Social Security and Family of Brazil’s House of Representatives held a hearing on 9 May 2013 on the scope of regulatory authority of Brazil’s National Health Surveillance Agency
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13 May 2013
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The US Food and Drug Administration (FDA) may still be in the midst of figuring out how to overhaul its medical device compliance approach in regards to quality, but a new report out from device
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