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TOP 10 RULES FOR EFFECTIVELY COMMUNICATING WITH REGULATORS – PART 2

June 26, 2018

In our last blog we discussed five rules to help companies prepare for their interactions and meetings with FDA.  But preparation doesn’t stop once you analyze your audience.  In fact, it’s only after the analysis that the real work begins. In this blog, we’ll talk about the next five rules…

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CHMP Meeting Keys to Success

June 20, 2018

OVERVIEW Within the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) assesses the applicant’s quality, safety and efficacy data deciding on whether to recommend marketing authorization to the EMA. 31 members: One representative from each EU member nation (28 voting members), plus 3 non-voting members…

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Top 10 Rules for Effectively Communicating with Regulators – Part 1

June 15, 2018

This month we spoke at the 2018 BIO International Convention in Boston, MA on How to Effectively Communicate with Regulators.  3D Communications has spent the last 15 years preparing companies for FDA pre-submission and advisory committee meetings.  During this time, we have developed our “Top 10 Rules” to help make…

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Insights and Issues From FDA Advisory Committee Meetings on Abuse-Deterrent Opioids

February 28, 2018

It is the current policy of the US Food and Drug Administration (FDA) to convene expert Advisory Committees to provide input on key regulatory decisions regarding opioid products, including approval and labeling of opioid abuse-deterrent formulations (ADFs). Advisory Committee meetings on ADF opioids consider whether the laboratory and clinical data…

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