Previous query about FDA Debarment Doug Wilkerson, Ph.D. 13 Jan 1995 08:09 EST

 Thanks to everyone who responded to my previous question concerning
FDA debarment.  Most of the responses equated FDA debarment with the typical
debarment from federal acquisition programs, but I am not sure that it IS the
same.  The FDA does not fund pharmaceutical company sponsored clinical trials,
but it does have to pass final judgement on the data obtained in the clinical
trials.  I rather suspect (without the burden of information to argue either
way) that being debarred by the FDA simply means that they will not accept
data generated by the debarred clinician in support of a company application
for FDA approval of a drug.  Anyone know whether my conjecture is correct or
not?

Doug Wilkerson, Ph.D.           VOICE:  (419) 381-4252
Assoc. V.P. for Research        FAX:    (419) 381-4262
Professor of Pharmacology       e-mail: xxxxxx@GEMINI.MCO.EDU
Medical College of Ohio
3000 Arlington Ave.
Toledo, OH 43614