Recent Posts
Growing consensus on the need to improve communications with health care professionals
By Mit Spears | March 3, 2016
Today, the wealth of information about medicines is more comprehensive and complex than ever before. Scientific knowledge and new findings go far beyond the parameters established by Food and Drug...
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Pacira settlement important step towards ensuring clinicians have access to the best available data on FDA-approved medicines
By Mit Spears | December 22, 2015
During last week’s FDA/CMS Summit for Biopharma Executives, I had the opportunity to discuss the many recent legal and regulatory developments regarding communicating scientific data and clinical...
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ICYMI: Physicians want better information sharing with biopharmaceutical companies
By Mit Spears | November 23, 2015
The issue and debate around communications with health care professionals is at its very essence, a conversation about ensuring physicians have the best possible data to effectively treat patients....
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The Pacira Case Study: Patients are better served when health care professionals have the most accurate and up-to-date medical information
By Mit Spears | November 13, 2015
Patients are better served when health care professionals have the most accurate and up-to-date medical information. This is true for data and information regarding FDA-approved uses and medically...
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ICYMI: The Wall Street Journal Makes the Case for Sharing Truthful, Non-Misleading Information
By Mit Spears | August 18, 2015
On Friday, The Wall Street Journal editorialized on free speech in the context of sharing scientific and medical information, something critical for the U.S. Food and Drug Administration (FDA). FDA’s...
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Embracing 21st Century Information Sharing: Defining a New Paradigm for the FDA and Communications with Health Care Professionals
By Mit Spears | April 1, 2015
The Food and Drug Administration (FDA) protects public health by approving new medicines for patients, ensuring unsafe treatments are not used and monitoring the evolution of scientific insights...
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Biopharmaceutical Companies Face Restrictions in Sharing Scientific Information to Improve Patient Care
By Mit Spears | October 29, 2013
Yesterday, I had the opportunity to speak at a conference of regulatory and compliance professionals – those who are dedicated to ensuring that regulation works.
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Labeling Your Health
By Mit Spears | July 26, 2012
A physician, equipped with the latest medical and scientific information, prescribes a medicine as the best course of treatment for a patient. The patient follows the doctor's orders, takes the...
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