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The Regulatory Affairs Professional Society (RAPS) Published a Positive Review of 3D Communications’ Book: 'The FDA Clinical Submission Survival Manual'

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.

To purchase the book, visit the 3D Bookstore or purchase via the RAPS web site.

 

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3D Communications Expands Executive Communications Programs and Training, Opens Boston Office

3D Communications announced today that it has opened an office in Boston, Massachusetts and significantly expanded its executive communications training programs to help companies communicate more effectively in increasingly complex and contentious environments. The expansion of communications services, and the opening of the Boston office, will allow 3D to better serve clients in New England and globally. 3D’s Executive Communications Programs and Training will now include: Leadership Communications Coaching, Change Management Communications, and Crisis Communications. These will be in addition to 3D’s current offerings of Messaging, Media Training, and Speaker Training services. To lead the Boston office, 3D has recruited Executive Communications Consultant and Former 60 Minutes Producer Lee Zeidman to join the team.

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Bridging the Gap Between Value and Affordability

Drug Discovery and Development featured an article by Jane Horvath, 3D Communications Market Access Lead, on Bridging the Gap Between Value and Affordability.

“Innovators need a clearer view of the innovations that are important to key therapeutic stakeholders, such as helping providers meet their performance metrics or improving patient quality of life. They need that knowledge well before product launch.  And they need to bring to market innovations that reflect and integrate those views.”

 

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Pfizer Would Explore Where No Other Firm Has Gone Before With Lipitor Switch

Jim DiBiasi, co-founder of 3D Communications, says consumers should be trusted to access information other than what is printed on product labels before deciding whether to use OTC drugs indicated for conditions that so far are not targeted in the nonprescription space.

“If a supplemental label is needed, add it. The bottom line is that FDA should be less restrictive in the Rx-to-OTC switch approval process,” DiBiasi said in an email.

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Before Lipitor Switch Final Exam, Pfizer Survey Studies Self Care

“Pfizer’s survey results reinforce what we’ve all known for years – consumers want more control over their health care options. Unfortunately, consumers are denied OTC access to many products,” 3D co-founder Jim DiBiasi said in an email.

“As the Pfizer survey showed, consumers known when to seek help from a doctor or pharmacist,” DiBiasi said.

For the full article, click HERE.

 

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