Home  /  What We Do  /  FDA / Regulatory Affairs Communication – FDA Advisory Committee Preparation Strategy

RAPS Texas Chapter Meeting

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

Read More

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.

Read More

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.

Read More

Virginia Cox, JD, former FDA Associate Commissioner re-joins 3D

3D Communications, a leading provider of strategic communications services to corporations and organizations preparing for major scientific, regulatory, business, and media events in the United States and Europe, today announced its former associate Virginia Cox, JD, is returning to the firm’s Washington, D.C. office.

Read More

Allison May Rosen Joins 3D as Communications Lead for FDA Advisory Committee Projects

Consultancy firm 3D Communications has named Allison May Rosen as communications lead for its projects related to the US Food and Drug Administration's (FDA) advisory committee. Rosen, a Washington DC-based healthcare communications strategist and trainer, joins from Chandler Chicco, where she ran the DC office and led public health and healthcare programmes.

Read More