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From: John The Revelator
Date: 5/7/2002
Time: 12:21:03 PM
Remote Name: 208.177.94.174
It basically means that the FDA will neither confirm nor deny anything that is in the pre-approval stage. This includes any correspondence with or applications from researchers, pharmaceutical or biotech companies, doctors, etc.
Anything which has been APPROVED is accessible to the public through an FOI request. According to the official I spoke with this morning, much of what FDA has approved will appear on their website, but not everything.
This is just FDA's policy for complying with the federal Freedom of Information Act. Unfortunately the Code of Federal Regulations gives certain agencies a great deal of leeway as to how they can comply with this federal law. In the case of the FDA, a great deal of discretion is given to the Commmissioner (the head of the FDA.) For some years now, the Commissioner's policy has been not to confirm nor deny any correspondence with any of the individuals or companies listed on an FDA request.
My personal feeling is that I wouldn't have been contacted if there was nothing to report at all. The agency has neither confirmed nor denied communication or applications from the named parties, but why did they take the time to write me a personal letter and invite me to have a conversation with this individual (who is pretty high ranking in the agency)?
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