In the lower left-hand corner of most FDA web pages is a date given as “page last updated.” The straightforward understanding of this would be that either the whole page or something substantive on the […]
In a January 2014 blog post, I reported on a third visit to the FDA’s own scorecard for its 2013 Action Plan. As of Jan. 1, 2015, this page showed a last updated date of […]
A challenge in the fast-moving medical device industry is the maintenance of up-to-date information. The U.S. Food and Drug Administration (FDA) faces this challenge in keeping its various online resources current and consistent. While FDA […]
In July 2013 and October 2013, I addressed the U.S. Food and Drug Administration’s progress in completing the various elements of improvements to its postmarket surveillance program. This effort has 14 parts divided among three […]
Back in July, I wrote about the first deadline that the U.S. Food and Drug Administration had set for itself with respect to a series of activities to improve its postmarket surveillance system. Of the […]
In recent years, the FDA’s premarket notification process has been challenged as an ineffective tool for assuring that safe and effective devices enter the marketplace. That criticism, however, is too broad and fails to recognize […]
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