Latest News
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17 April 2013
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New draft guidance documents released by the International Medical Device Regulators' Forum (IMDRF) aim to establish new standards for medical device auditing and monitoring organizations, as well as
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8 April 2013
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A new draft guidance issued by the US Food and Drug Administration (FDA), Molecular Diagnostic Instruments with Combined Functions, aims to clarify the standards by which federal regulators will
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3 April 2013
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A new guidance document posted by the US Food and Drug Administration (FDA) on the use of glass syringes to deliver pharmaceutical and biological products looks to build upon an existing international
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Regulatory Update
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3 April 2013
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Health Canada has released revised draft guidance concerning the safety and efficacy requirements necessary to obtain market authorization for disinfectants and disinfectant-sanitizers in Canada.The
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Regulatory Update
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29 March 2013
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The UK’s National Institute for Health and Clinical Excellence (NICE) will not recommend reimbursement for Pfizer’s new kidney cancer drug Inlyta (axitinib) as a result its comparison data, the agency
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Regulatory Update
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20 March 2013
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In draft guidance released on 20 March 2013, the UK's National Institute for Health and Clinical Excellence (NICE) recommends against National Health Service (NHS) reimbursement for Novartis’ breast
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Latest News
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11 March 2013
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The US Food and Drug Administration (FDA) is over-reaching on its planned list of medical device guidance documents, claims a comment notice filed by industry group AdvaMed, which says FDA needs to
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8 March 2013
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The Center for Drug Evaluation and Research (CDER), the US Food and Drug Administration's (FDA) primary drug regulatory body for chemical and biological drugs, has released a comprehensive list of all
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8 March 2013
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The US Food and Drug Administration (FDA) has published a new draft guidance document regarding the labeling of medical products not made with natural rubber latex (NRL).NRL is found in numerous
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Regulatory Update
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7 March 2013
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The UK’s National Institute for Health and Clinical Excellence (NICE) today published final draft guidance recommending omalizumab (Xolair, Novartis Pharmaceuticals UK) as an option for treating
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