Latest News
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21 May 2013
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The medical device industry is weighing in on a recent guidance document published by the US Food and Drug Administration (FDA), in several instances calling it deeply flawed and in need of
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16 May 2013
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The US Food and Drug Administration (FDA) has released two long-awaited guidance documents regarding the appeals process to be used by medical device manufacturers that have received a rejection by
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16 May 2013
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A new guidance document released by US federal regulators aims to establish best practices for conducting and reporting pharmacoepidemiologic safety studies that are conducted using electronic
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10 May 2013
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The US Food and Drug Administration (FDA) has released a final guidance document that it says is intended to expedite the donation of blood and plasma for frequent donors.BackgroundThe final guidance,
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Latest News
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24 April 2013
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A new guidance document just published by the US Food and Drug Administration (FDA) is intended to present a "least burdensome regulatory approach" for sponsors of class III in vitro diagnostic
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17 April 2013
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The US Food and Drug Administration (FDA) has just published a new guidance document that finalizes its manufacturing framework for the production of many antibiotics.BackgroundFDA closely regulates
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12 April 2013
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The US Food and Drug Administration (FDA) has released a new guidance document finalizing its recommendations for the medical device industry on how to use Classification Product Codes (CPC), a
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Latest News
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11 April 2013
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A new final guidance document issued by the US Food and Drug Administration (FDA) provides recommendations for the pharmaceutical industry on how to develop and conduct self-selection studies in
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4 April 2013
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A new guidance document published by the US Food and Drug Administration (FDA) establishes and otherwise clarifies the process by which biopharmaceutical and medical device companies need to pay user
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Latest News
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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