Bioresearch Monitoring Alert articles from February 2002

Bioresearch Monitoring Alert archives from February 2002

FDA plans 44% increase in BiMo audits, particularly overseas; OHRP budget increases for '03.(Food and Drug Administration to increase bioresearch monitoring inspections; budget also increased for Department of Health and Human Services' Office of Human Research Protections)(Brief Article)
February 1, 2002... ROCKVILLE, MD - Aided by a huge budget increase from President Bush, which represents new money, not funds that will be consumed by cost-of-living increases, FDA will be able to do conduct about 44% more bioreseach monitoring inspections...

Agency officials recommend independent DMCs, caution against overexposure of interim data.(Food and Drug Administration urges drug companies to appoint data monitoring committees to monitor clinical trials)(Brief Article)
February 1, 2002... BETHESDA, MD - FDA officials are urging private industry to appoint data monitoring committees (DMC) that are independent of the clinical trial sponsor - even to the point of not having sponsors sit on the panel - and which do not peek at...

Companies thinking globally about patient enrollment must first act locally.(problems in enrolling patients in clinical trials)
February 1, 2002... When Patient Quest, Chicago, IL, launched a project to study patient recruitment and retention figures for clinical studies, they uncovered some disturbing statistics. Kathleen Drennan, chief of global marketing and strategic business...

Enron, ADM cases send message - corporate compliance critical.(companies must be vigilant in complying with laws and procedures)(Brief Article)
February 1, 2002... A federal judge in Chicago, who handed out $100 million in fines in 1996 to a major grain producer for price fixing, says that case, along with the Enron matter unfolding in Washington, hold lessons for the clinical research community as well....

Merck responds to draft guidance on DMCs with concern over statements regarding statisticians.(data monitoring committees)(Brief Article)
February 1, 2002... In the first public comment on FDA's draft "Guidance for Clinical Trial Sponsors on the Establishment and Operations of Clinical Trial Data Monitoring Committees," Merck disagreed that statisticians be independent from sponsors. The Jan....

CI hit with 483, warning letter for widespread violations.(cancer investigator Lloyd A. Shabazz)
February 1, 2002... Lloyd A. Shabazz, M.D., Cancer Treatment Centers of America, Portsmouth, VA, Baltimore District Lloyd Shabazz, M.D. was hit with a 13-page 483 and a warning letter after an inspection involving three studies for which the physician was the...

Investigator's records receive good bill of health despite 483.
February 1, 2002... Jeffrey R. Breiter, M.D., Center for Medical Research, Manchester, CT, Hartford District Clinical investigator Jeffrey Breiter, M.D. fared well in a May, 2000 FDA inspection despite a one-item 483. FDA inspector Anthony Warchut, of...

Investigator enrolls patients before obtaining IRB's blessing, gets 483.(Brief Article)
February 1, 2002... Debra Breneman, M.D., University Dermatology Consultants, Cincinnati, OH, Cincinnati District Debra Breneman, M.D. received a rather repetitive five-item 483 after an inspection revealed many incidents of enrolling subjects who fell...

FDA visits SMO to resolve unanswered questions from site inspection.(site management organization)(Brief Article)
February 1, 2002... Health Advance Institute, Peoria, IL, Chicago District Site management organization (SMO) Health Advance Institute (HAI), Peoria, IL, received a visit from FDA as a result of some confusing tests results uncovered three months before,...

Ricerca gets citations for failure to observe SOPs.(standard operating procedures)(Brief Article)
February 1, 2002... Ricerca, Painesville, OH, Cincinnati District Failure to follow SOPs were key faults that yielded a four-item 483 for Ricerca following a GLP audit in March-April 2000. The inspection was conducted by Stephen Kilker of FDA's Cincinnati...

Surprise CRO inspection reveals serious problems with former employee.(contract research organization Parexel)(Brief Article)
February 1, 2002... Parexel, Waltham, MA, Stoneham, MA District Contract research organization Parexel received a visit by an FDA inspector that concluded with a 483 for failure to act within timeframes specified in the study protocol. Constance DeSimone of...

BiMo FOIA Log.(bimonthly Freedom of Information Act listing of requests filed with Food and Drug Administration)(Brief Article)
February 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.(from FDA to three medical researchers)(Brief Article)
February 1, 2002... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors and CROs and testing labs that have been released since Jan. 10, 2002. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number...