Regulatory Update
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20 May 2013
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The China Food and Drug Administration (CFDA) has issued a notice setting deadlines for implementing electronic monitoring for imported essential drugs. Imported drugs in domestic packaging must
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Regulatory Update
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8 March 2013
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In the latest collaboration since Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medsafe agreed in 2011 to proceed with a joint scheme for the regulation of therapeutic products,
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Latest News
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13 September 2012
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Canadian healthcare regulators have released a new framework for conducting postmarketing vigilance activities on healthcare products, saying it is intended to "conceptually describe Canada's future
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16 August 2012
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A group of 13 senators is calling on the US Food and Drug Administration (FDA) to tighten the requirements of recently-released antibiotics guidance documents.The guidance documents, released in April
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7 August 2012
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Top officials in the US Food and Drug Administration (FDA) were personally involved in reviewing and approving a surveillance program which targeted group of whistleblowers within the agency, reports
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Regulatory Update
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3 August 2012
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Pharmaceutical manufacturers will bear primary responsibility for assuring the quality of the excipients used in their products according to a new regulation announced by China’s State Food and Drug
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17 July 2012
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The US Food and Drug Administration (FDA) is facing mounting pressure from both Congress and outside groups after The New York Times published an exposé on a clandestine monitoring program at the
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21 June 2012
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A federal agency tasked with protecting whistleblowers has released a new guidance to other federal agencies urging them to “heed whistleblower rights when monitoring employee communications”—a
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Regulatory Update
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18 April 2012
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The Canadian Agency for Drugs and Technologies in Health (CADTH) Rapid Response Report found in patients with type II diabetes no statistically significant difference between two self-monitoring
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Latest News
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17 April 2012
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After a string of “headline-grabbing” recalls involving medical devices in recent months, Minneapolis-based medical device manufacturer Medtronic is announcing its intent to increase its postmarketing
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