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30 July 2012
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After a four-month pilot period, EU regulators are proposing to make permanent a program that allows applicants and sponsors of marketing authorization applications to submit their entire dossiers
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30 July 2012
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The European Medicines Agency (EMA) has announced the publication of a new policy on making changes to pediatric investigation plan (PIP) decisions.PIPs are mandated by Regulation EC 1901/2006, which
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27 July 2012
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The US Food and Drug Administration (FDA) is potentially on pace to approve fewer new drug entities than it did in 2011, according to several sources.An analysis by The Street of the remaining 2012
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27 July 2012
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Regulatory Focus is proud to bring you another edition of Week in Review—a recap of the global regulatory news space for the preceding week. We cover news and regulatory intelligence from around the
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27 July 2012
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Newly-proposed legislation introduced in the US House of Representatives would allow companies to submit to a voluntary process to label their products "Cancer-Free" if they do not contain known
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27 July 2012
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The US Food and Drug Administration (FDA) is widely known as the country’s chief federal regulator of biological products. Lesser-known—but still important—is another federal program known as the
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27 July 2012
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The US Food and Drug Administration (FDA) has released an advanced notice of proposed rulemaking—the precursor process for promulgating a regulation—saying it wants to reassess the information
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27 July 2012
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The US District Court in Washington, DC, has ruled that the US Food and Drug Administration (FDA) may legally regulate stem cell therapies as drug products—an opening salvo in what is likely to be a
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26 July 2012
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Russia's top regulator is claiming Russian regulators are handicapped in the fight against counterfeiting because no penalties exist under Russian law to prohibit the sale and production of
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26 July 2012
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The US House of Representatives passed a bill that would freeze many regulations, including those introduced by the US Food and Drug Administration (FDA), until unemployment falls to pre-recession
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