Guest guest Posted May 28, 1999 Report Share Posted May 28, 1999 About Tylenol PM - try it if you wish, everyone IS definitely different, but for me it was one of the worst nights I've ever spent. It made me very sleepy, but my legs were very active. Therefore I was walking my legs & shaking my arms, ad literally falling in the floor because I was so sleepy. Ninette Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 26, 2004 Report Share Posted May 26, 2004 I don't see anything in the warning letter that indicates any problem with the C+ device or techniques (assuming that is the device in question - all references have been redacted) but it does look like (or their contractors) didn't do a very good job of controlling the trials. This may have the unfortunate effect of delaying FDA approval. A plea to all US Surface Hippies, please keep your follow-up appointments so the follow-up data can be reported! Future Surface Hippies are counting on us! RC2K Dr. Gross 3/24/04 > The letter is located at: www.fda.gov/foi/warning_letters/g4697d.htm > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 26, 2004 Report Share Posted May 26, 2004 I don't see anything in the warning letter that indicates any problem with the C+ device or techniques (assuming that is the device in question - all references have been redacted) but it does look like (or their contractors) didn't do a very good job of controlling the trials. This may have the unfortunate effect of delaying FDA approval. A plea to all US Surface Hippies, please keep your follow-up appointments so the follow-up data can be reported! Future Surface Hippies are counting on us! RC2K Dr. Gross 3/24/04 > The letter is located at: www.fda.gov/foi/warning_letters/g4697d.htm > > Quote Link to comment Share on other sites More sharing options...
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