Bioresearch Monitoring Alert articles from January 2002

Bioresearch Monitoring Alert archives from January 2002

3% of BiMo audits were OAI in FY '01; low compared to other FDA audit areas.(official action indicated, biological monitoring)(United States. Food and Drug Administration)(Brief Article)(Statistical Data Included)
January 1, 2002... BOSTON -- About 3% of all BiMo inspections in FDA's fiscal year 2001 were rated "official action indicated" (OAI), meaning a 483 was issued, and possibly other regulatory action, a top FDA official told the 15th annual meeting of the Applied...

FDA seeks to waive informed consent for bioterrorism and military situations; IRB registration in offing, too.(United States. Food and Drug Administration)(Brief Article)
January 1, 2002... FDA plans to propose a rule by March to allow the waiver of informed consent to use investigational products in "response to chemical and biological terrorism," lifting of informed consent in military situations and regulations to require IRB...

FDAers recommend cultivating whistleblowers, home in on data.(United States. Food and Drug Administration)(Brief Article)
January 1, 2002... Sponsors and monitors of clinical trials should try to cultivate whistleblowing within their organizations and really examine medical records to weed out misconduct. That's the advice two top FDA BiMo officials gave to a Society for...

Compliance costs at Cedar-Sinai up five-fold in two years.(Cedars-Sinai Medical Center)(Brief Article)
January 1, 2002... ANAHEIM, CA -- The high cost of compliance with FDA and Office of Human Research Protections (OHRP) rules hit home here at a recent meeting of the Health Care Compliance Assn., where a vice president of a major Los Angeles research hospital...

Failure to even train staff could mean fines, suits.(Brief Article)
January 1, 2002... ANAHEIM, CA -- Failure to train clinical research staff could mean a loss of grant money, lawsuits or even jail time in an extreme case, an attorney told a recent Health Care Compliance Assn. conference here. Kendra Dimond, an attorney...

Inspector unable to determine extent of study director involvement at Argus.(Brief Article)
January 1, 2002... Argus Research Laboratories, Horsham, PA, Philadelphia District Argus Research Labs fared well in a GLP inspection of its non-clinical facility despite a few concerns on the part of the investigator. Although there were some small bumps...

Lab earns 483 for inconsistencies between study file, final report.(Batelle Memorial Institute)(Brief Article)
January 1, 2002... Batelle Memorial Institute, Columbus, OH, Cincinnati District FDA's white glove once again uncovered dust in a non-clinical CRO. Batelle Memorial Institute underwent a GLP inspection that lasted from mid-April to the end of May 2000. The...

GCP/GLP audit results in 483, revamped operating procedures for facility.(Leonard J. Caputo, M.D., The Allergy and Asthma Institute)(Brief Article)
January 1, 2002... Leonard J. Caputo, M.D., The Allergy & Asthma Institute, Mobile, AL, New Orleans District A combined GCP/GLP inspection of clinical investigator Leonard Caputo, M.D., yielded a six-item 483 that included citations for altering data that...

Audit at UCLA shows investigator ran a tight ship; got no 483.(University of CalifoUniversity of California (Los Angeles))(Brief Article)
January 1, 2002... Robert S. Bennion, M.D., Olive View/UCLA Medical Center, Sylmar, CA, Los Angeles District Clinical investigator Robert Bennion, M.D., received a clean bill of health from FDA in its inspection at the Department of Surgery at Olive...

Doctor gets good marks in first FDA audit, but one-item 483.(Brian L. Warren, M.D., Stellenbosch University, South Africa)(Brief Article)
January 1, 2002... Brian L. Warren, M.D., Stellenbosch University, Tygerberg, South Africa, Foreign Inspection Team A South African clinical investigator got a passing grade from FDA on his first BiMo inspection. Brian Warren, M.D., a professor in the...

BiMo FOIA Log.(Freedom Of Information Act)(Brief Article)
January 1, 2002... This is a list of FOIA requests for copies of 483s and EIRs for inspections of CROs, testing labs, sponsor/monitors, IRBs and clinical investigators, which were filed with FDA under the Freedom of Information Act (FOIA). This list does not...

Warning Letters.(United States. Food and Drug Administration)(Brief Article)
January 1, 2002... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors and CROs and testing labs Dec. 3 to Jan. 2, 2002. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e., 9007W, 9008W,...

IRB Determination Letters.(compliance determination letters)(United States. Office for Human Research Protections)(Brief Article)
January 1, 2002... The following are Compliance Determination Letters for IRBs issued in December by the Office for Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to these letters also are available by calling...