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27 February 2013
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A guidance document released by the US Food and Drug Administration (FDA) looks to clarify the requirements associated with the disclosure of financial holdings by clinical investigators that could
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27 February 2013
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The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has released a new guidance document aimed at adopting a new and more flexible recommendation for the
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Latest News
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15 February 2013
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A new final guidance document released on 15 February 2013 by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is intended to assist sponsors of surgical
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7 February 2013
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A new draft guidance document released by the US Food and Drug Administration (FDA) seeks to provide sponsors with a better understanding of how it intends to regulate drug products that treat a
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Regulatory Update
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4 February 2013
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Brazil’s National Health Surveillance Agency (Anvisa) has issued a Guide to Quality Water Purification Systems for Pharmaceutical use which is directed to pharmaceutical manufacturers in Brazil. The
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Latest News
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29 January 2013
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The US Food and Drug Administration (FDA) has released a new final guidance for industry explaining the E3 Structure and Content of Clinical Study Reports guideline, part of ongoing efforts by
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25 January 2013
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A meeting proposed by US regulators would seek to bring together the US Food and Drug Administration (FDA), pharmaceutical trade industry group PhRMA, the regulatory science-focused Critical Path
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25 January 2013
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The US Food and Drug Administration (FDA) has released a new final guidance document on clinical pharmacogenomics that it says should help sponsors to better conduct premarket evaluations in
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3 January 2013
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The US Food and Drug Administration (FDA) has released three final guidance documents regarding the submission of nearly all medical device applications made to the agency.The guidance documents,
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Regulatory Update
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2 January 2013
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Health Canada has opened a consultation regarding the new Prescription Drug List that is scheduled replace the existing Schedule F of the Food and Drug Regulations. The regulatory process to add or
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