January 2010
Intermediate to advanced
33 pages
39m
English
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THE TRUST |
DIVIDEND |
In a December, 2000 article in Regulatory Affairs Focus, my colleague and friend, Ira Asherman makes a strong case for pharmaceutical companies building a trusting relationship with the Food and Drug Administration (FDA).
In the end, Asherman believes that trust between the FDA and the drug companies will pay dividends to both organizations. He believes that drug development teams that focus on relationship management to stop “demonizing” the agency, understand the agency’s needs, communicate openly about safety issues and, when appropriate, admit their mistakes, will be successful.
And, in the end, success translates into more rapid approval of new drug applications.
Discussion Guide:
What do you think of this approach? ...