In a press release dated August 7 the FDA announced that it was going to enhance the speed and transparency of actions taken against research misconduct in drug and medical device development. FDA stated that the revamped debarment and disqualification proceedings would increase protection of participants in clinical trials and ensure data integrity. Debarment and disqualification of a clinical investigator are the most serious enforcement actions that FDA can take short of criminal prosecution.
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Reform is needed here. I heard from my contacts in FDA that it took 15 years before a clinical investigator in CVM was disqualified. The person was a major researcher in new animal drugs. Iagine the number of applications approved his data.
Carl, I was unable to get the name of the clinical investigator. I could not find it on FDA FOIA Website. I am hoping you can find out from your BIMO contacts.