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23 May 2013
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EU regulators with the European Medicines Agency (EMA) have announced the issuance of six recommendations stemming from a workshop they recently conducted regarding methods to reduce medication
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9 April 2013
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The US Food and Drug Administration's (FDA) device regulatory division wants to know: Are medical devices meeting the unique needs of women?That question is behind a newly announced workshop the
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2 April 2013
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The electronic Common Technical Document (eCTD) provides a common global standard for companies to electronically submit the quality, safety and efficacy information required by regulatory agencies. It is an EMA requirement and will soon be required by FDA, so anyone working on drug regulatory submissions needs to understand the format well.
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26 March 2013
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An upcoming meeting co-sponsored by the International Color Consortium (ICC) and the US Food and Drug Administration (FDA) seeks to address questions regarding the interoperability of medical imaging
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14 March 2013
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The US Food and Drug Administration (FDA) is planning to hold a meeting along with members of industry and various and diverse government agencies in April to work through issues related to the
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13 February 2013
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A new report just published by the US Institute of Medicine (IOM) and sponsored by the US Food and Drug Administration (FDA) finds that global regulators and regulatory systems need to do more to
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11 February 2013
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Even casual observers of US healthcare policy are aware of a common refrain: Costs are too high, unsustainable and a poor indicator for the quality US patients ought to be receiving. While the reasons
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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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28 November 2012
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The Institute of Medicine (IOM) wants the practice of regulatory affairs to be a little bit easier, particularly for low-resource countries and companies conducting international clinical trials.In an
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12 September 2012
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Officials from the US Food and Drug Administration (FDA) are planning to hold a workshop in October to study the use, validity and reliability of medical devices used to image glaucomas, the agency
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