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

Jim Dibiasi, co-founder of NDA consultancy 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.

For the full article, click HERE.

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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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3D Communications Expands Market Access and Reimbursement Communications Services for Pharmaceutical Companies. Senior Executive Jane Horvath Joins 3D to Lead Program

3D Communications announced today that it has significantly expanded its process for helping pharmaceutical companies communicate the value of their drugs and maximize patient access. The newly expanded 3D Market Access and Reimbursement Communications services will go beyond helping companies develop and deliver their “Value Story”. It will also provide a process to identify and engage critical stakeholders earlier in the “innovation-to-market” timeline, and incorporate critical learnings throughout the development process.

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3D Communications Contributes to European Regulatory Organization Publication

The November issue of the TOPRA Regulatory Rapporteur features an article entitled “FDA Advisory Committee Meetings: What they are? Why do they happen? and What do they mean for regulatory professionals?”

The article provides a brief history of the purpose and significance of advisory committee meetings, details how a sponsor can best prepare for these high-stakes events, and discusses how an FDA Advisory Committee Meeting can impact a companies’ development plans.

Virginia Cox, JD, a Senior Consultant with 3D Communications, co-authored the article. Before joining 3D, Virginia was the Associate Commissioner for the Office of External Affairs at the U.S. Food and Drug Administration (FDA). Her FDA experience, along with her role as a Communications Lead on numerous 3D FDA Advisory Committee projects, uniquely qualifies her to provide important perspectives on this topic.

For the full article, click HERE.

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