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FDA
FDA Issues Draft Guidance on Medical Device User Fee and Modernization Act
The Food and Drug Administration (FDA) gave notice to the public of a Proposed Guidance Development on the Web for the Medical…
FDA Announces Strategic Plan for Risk Communication
The FDA today announced a Strategic Plan for Risk Communication that establishes a framework for communicating meaningful health…
FDA Hires IOM to Review Medical Device Approval System
The Food and Drug Administration (FDA) recently issued a press release announcing the commissioning of the Institute of…
FDA Hearing on Internet and Web 2.0
At the beginning of the year the Food and Drug Administration (FDA) sent warning letters to 10 companies concerning…
FDA: Transparency Taskforce — Industry + Anti Industry (No middle…
This past week the FDA held their first Transparency Taskforce meeting headed up by Deputy FDA Commissioner Joshua…
FDA: Forms Transparency Taskforce
In the past, the Food and Drug Administration (FDA) has been criticized as a “black box that makes important decisions without…
FDA: Pharmaceutical Cheerios?
I did not realize there were negative side effects or addiction problems with Cheerios but apparently the FDA thinks Cheerios are…
FDA: Presenting Risk Information in Prescription Drug and Medical Device…
This week, the U.S Food and Drug Administration (FDA) issued a draft Guidance for Industry titled "Presenting Risk Information…
FDA: Presenting Risk Information in Prescription Drug and Medical Device…
The Coalition for Healthcare Communication will be filing extensive comments on the FDA draft Guidance and solicits your…
FDA: Consider Faster Approval for Cancer Medications
Richard Epstein, PhD, Economist from the University of Chicago in the Wall Street Journal reviews the importance of off-label…