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3D to be Exhibitor at AdvaMed 2014 MedTech Conference

October 6 - October 8, 2014 Chicago, Illinois

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3D to be Exhibitor at the 2014 RAPS Regulatory Convergence

September 27 - October 1, 2014 Austin, Texas

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RAPS Texas Chapter Meeting

July 17, 2014 The Steps to a Successful Advisory Committee or Device Panel Meeting  

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Thriving Again in 2014: Preparing for Success, Not Just Survival at FDA Advisory Committee Meetings

Building on the high energy panel discussion session at the 2013 BIO International Convention, this panel returns for a current look at the dos and don'ts for managing FDA advisory committee meeting activities.

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How FDA Advisory Committee Members Prepare and What Influences Them

Since 1992 many changes have occurred in the regulations, guidelines, and processes governing the FDA, the biomedical industry, other stakeholders, and their interactions. Of particular importance, the FDA Amendments Act of 2007 made public advisory committee meetings mandatory for new molecular entities and devices requiring clinical trials, unless the necessity of convening such a meeting has been waived by the FDA commissioner.

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