Category Archives: Regulations

The Effects of the New FDA Rule for medical device investigations conducted outside the United States

  On February 21, 2019 the new US FDA rule on medical device clinical investigations conducted outside the United States (OUS) became effective. In this post, we would like to discuss the difference between the old and the new regulation and … Continue reading

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The EMA and Foreign Data_Part 2

Previously we looked at data from the European Medicines Agency, which showed the increasing role since 2005 that some ‘Rest of the World’ nations were playing in enrolling patients in clinical trials supplying pivotal data for marketing authorisation applications (MAAs) … Continue reading

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The EMA and Foreign Data_Part 1

In recent years we have seen an increase in the number of trials conducted for EU marketing authority applications (MAA) in areas other than what was considered to be in the two main European [European Union (EU) / European Economic … Continue reading

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MEDICAL DEVICE COMPANIES CAN RELY ON SOUND FOREIGN CLINICAL DATA SAY NEW DRAFT FDA GUIDELINES

New draft guidance has just been issued by the US Food and Drug Administration (FDA), which aims to make it easier for medical device companies to rely on data obtained from clinical studies conducted outside the United States (conveniently termed … Continue reading

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The reference for writing Clinical Study Report [Clarity and Openness in Reporting: E3-based (CORE)] and the guidance for writing Clinical Study Protocol – a new initiative of the European Medical Writers Association and the American Medical Writers Association_Part 2

Though the CORE (Clarity and Openness in Reporting: E3-based) Reference is planned to be available in the mid-2016, it is very likely that BWG review and analysis will be shared for review at the end of the first quarter of … Continue reading

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The reference for writing Clinical Study Report [Clarity and Openness in Reporting: E3-based (CORE)] and the guidance for writing Clinical Study Protocol – a new initiative of the European Medical Writers Association and the American Medical Writers Association_Part 1

All over the world and across different nations and cultures, the standardisation in managing and providing clinical research is not a dream anymore, but it’s a reality with still growing awareness of the importance of international clarity and harmony in … Continue reading

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The goal: improvement in safety of medicines

As our life is strongly influenced by the fast growth of the pharmaceutical industry, there is an urgent need for control of their products. Safety of drugs available on the market depends on proper reporting procedures of any adverse drug … Continue reading

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