The Regulatory Affairs Professional Society (RAPS) Published a Positive Review of 3D Communications’ Book: ‘The FDA Clinical Submission Survival Manual’
Source: Regulatory Affairs Professionals Society
Meredith Brown-Tuttle, RAC, chair of the RAPS Publication Task Force, recently reviewed 3D Communications FDA Clinical Submission Survival Manual.
In her review, Ms. Brown-Tuttle notes that, “The quality of a regulatory professional’s communication skills can make or break a company. The FDA Clinical Submission Survival Manual contains useful tips and processes to improve FDA communication. It contains specifics on how to plan, develop and test strategy and key messages for a marketing application, with a focus on clinical data.”
“The book could be a good primer for those interested in moving up the ‘ladder,’ especially for those wanting to understand the marketing application planning process and accompanying pitfalls. It also will be useful for those at a senior level who have been through the NDA process, but would appreciate external validation or support for implementing new processes.”
For the full review visit the RAPS site here.