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Warning letters.
The following are FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs, which were released in October 2002. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e., 12069W). Copies of responses to these letters, along with any 483s and EIRs, are available from RECORD-RETRIEVE: contact us at : (703) 779-8777, or DOCS@FDAINFO.COM.
12069W
Harry Bear, M.D., Ph. D., Richmond, VA, Sept. 27 (CBER-OCBQ). The letter stated Bear failed to ensure that an unnamed clinical melanoma vaccine study at Virginia Commonwealth University was conducted according to the investigational plan. FDA acknowledged a May 13 …
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- CI violations for CBER higher than other FDA centers: Cole.(BiMo...
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Newspaper article from: Bioresearch Monitoring Alert
Sami, Tamra
July 1, 2003
700+ words
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- CBER wants to disqualify investigators within six months not six...
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Newspaper article from: Bioresearch Monitoring Alert
Whipple, Dan
September 1, 2001
700+ words
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- After warning letters for sponsor/monitor, clinical investigator, human...
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Newspaper article from: Bioresearch Monitoring Alert
April 1, 2002
700+ words
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- Warning Letters.(United States. Food and Drug Administration)(Brief Article)
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Newspaper article from: Bioresearch Monitoring Alert
January 1, 2002
700+ words
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- FDA plans 44% increase in BiMo audits, particularly overseas; OHRP budget...
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Newspaper article from: Bioresearch Monitoring Alert
Reid, Ken
February 1, 2002
700+ words
