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14 January 2013
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2012 was a momentous year for both the regulatory profession and Regulatory Focus. In our first year as an online-only publication, we covered a quickly changing landscape, dealing with topics that
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2 January 2013
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The US Food and Drug Administration (FDA) has ended the year on a high note, approving a flurry of new pharmaceutical products, taking its 2012 approval total to a 15-year high.US regulators approved
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6 December 2012
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The US Food and Drug Administration (FDA) has approved the same number of drugs during the 2012 fiscal year as it did in 2011, a new FDA report claims—the best two-year approval record in 15 years.The
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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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Regulatory Update
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10 May 2012
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Brazil’s reorganized national regulatory agency, Anvisa, said in remarks it is focused on establishing “a regulatory environment conducive to innovation."The remarks, by Anvisa’s CEO Dirceu Barbano,
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Regulatory Update
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23 April 2012
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ANVISA’s Advisory Council—a group including representatives of the National Confederations of Industry (CNI), Commerce (CNC) and Health (CNS) and councils that represent the health secretaries of
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Regulatory Update
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16 April 2012
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The 2012 Regulatory Agenda of the National Agency of Sanitary Surveillance (ANVISA) was published on 12 April in the Official Gazette (DOU) and includes the expansion of the national product
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30 March 2012
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The US Food and Drug Administration’s (FDA) top device regulator, Jeffery Shuren, director of the Center for Devices and Radiological Health (CDRH), testified before the Senate Health, Education,
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6 March 2012
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The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released 5 March a list of all new and revised guidance documents that the agency plans to release during
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13 January 2012
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Right on schedule, the US Food and Drug Administration (FDA) today confirmed that it has finished work on three user fee programs that will be sent to the Congress immediately.In a blog posting on the
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