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mookie
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FDA - used to - have one of the most transparent government sites in the world. I agree with the comment that it is impossible to search, so just use Google advanced search and limit searches to site:fda.gov and the results are different and much better. I personally dont bother with the site search function on fda.gov anymore. Almost all the questions asked on here so far can be answered on the site, and many organizations and universities provide courses and materials that tell people where to find the answers. A consumer should not be expected to spend $500 for a day course or $5,000 for a semester but any industry or investor that wont invest in that, frankly, is just not interested in finding the real answer. (Perhaps some keep looking because they want the answer that they WANT, not the right answer.) If they want the latest scientific requirements they need to hire staff to know that, and not count on FDA to know it for them. FDA will never be able to be as current as every single manufacturer on every product, so each company has an obligation to stay on top of its own products. That's they way the law is writen and the way the core function of FDA is designed. The costs of research and approval are on the applicant, not the government. The OLD CDRH website leading interested persons through its site and the regulatory process for devices was wonderful, but in the web redesign, instead of making the other Centers provide that, under the banner of uniformity, Device Advice is buried and much harder to navigate now. Bring it back. Make all the Centers follow it. Until FDA is fully staffed, investing in transparency diverts the little staff there is from appprovals and compliance. In sum, at least since its response to the AIDS crisis, FDA has been transparent to professionals and organizations who need to know and who make the effort to learn. However, the new website does not improve transparency but makes it worse.
Toggle Commented Oct 21, 2009 on FDA 101 Curriculum at FDA Transparency Blog
1 reply