Bioresearch Monitoring Alert articles from May 2003

Bioresearch Monitoring Alert archives from May 2003

CDER BiMo inspections up slightly in '02, but some categories see a drop. (BiMo inspections).(Center for Drugs, US Food and Drug Administration)
May 1, 2003... The Center for Drugs, which has the largest bioresearch monitoring inspection program in FDA, conducted more clinical researcher and IRB inspections in fiscal year 2002 (ended Sept. 30), but fewer audits of sponsor/monitors and overseas sites....

Consent form language 'needlessly complicated'. (Informed consent).
May 1, 2003... PHILADELPHIA -- An Essex IRB survey shows that only 12% of respondents given an informed consent form to read could understood what an IRB was and even fewer could identify medical terms that were critical to the experimental therapy about to...

Convicted in Borison case, Diamond urges monitors to follow GCPs. (Fraud and misconduct).(Medical College of Georgia, clinical research fraud)
May 1, 2003... PHILADELPHIA -- "If you think you are doing something wrong, you need to ask yourself, 'Do the risks outweigh the benefits?' In my case, the answer was yes." But Bruce Diamond took those risks and wound up in jail for five years, along...

For GLPs, quality unit can be extension of FDA or means to help lab staff, or both. (Quality assurance).(Good Laboratory Practice; US Food and Drug Administration)
May 1, 2003... PHILADELPHIA -- The proper role of the quality assurance unit (QAU) can be an extension of FDA, a means to support and help lab personnel, or both. Addressing a Center for Pharmaceutical Training conference here April 29-30, executives...

Early preparation ensures successful GLP inspections. (GLPs).(Good Laboratory Practice)
May 1, 2003... PHILADELPHIA -- A "continuum of readiness" is the recommended strategy for anticipating GLP inspections, according to John Kobland, manager of regulatory compliance at Schering-Plough Animal Health in Union, NJ. Advocating a constant state...

Documentation issues follow Florida investigator from NIH. (Sponsor-monitors/GLP).(National Institutes of Health, University of Florida; assays for drug)
May 1, 2003... Mark Brantly, M.D., University of Florida College of Medicine, Gainesville, FL, Florida District FDA came knocking on the doors of Mark Brantly, M.D., of the University of Florida College of Medicine, to investigate a sponsor's central...

Batelle receives 483 for inadequate maintenance of facility, procedural issues in GLP inspection. (Sponsor-monitors/GLP).(Batelle Memorial Institute, Good Laboratory Practice inspection)
May 1, 2003... Batelle Memorial Institute, Columbus, OH, Cincinnati District This follow-up GLP surveillance inspection of Batelle's Columbus non-clinical laboratory was initiated at the request of Joanne Rhoads, director of CDER's Division of Scientific...

Numerous informed consent issues, missing files lands CI 483. (Clinical investigators).(University of Florida, McKnight Brain Institute; clinical investigator, inspection)
May 1, 2003... Wayne Goodman, M.D., University of Florida, McKnight Brain Institute, Gainesville, FL, Florida District Clinical investigator Wayne Goodman, M.D., did not fare well for his first FDA inspection, which took place Jan. 22-24, 2002, according...

FDA can find no objections in CI audit. (Clinical investigators).(Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio; clinical investigator, US Food and Drug Administration)
May 1, 2003... Jeffrey Whitmer, M.D., Metabolic and Atherosclerosis Research Center, Cincinnati, OH, Cincinnati District Clinical investigator Jeffrey Whitmer, M.D., emerged squeaky clean following a six-day FDA inspection conducted by Joseph Kaufman of...

BiMo FOIA log.
May 1, 2003... This is a list of FOIA requests for copies of 483s monitors, IRBs and clinical investigators, which and EIRs for inspections of CROs, testing labs, sponsor/ were filed with FDA under the Freedom of Information Act (FOIA). This list does not...

Warning letters.(US Food and Drug Administration letters; clinical investigators)
May 1, 2003... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors and CROs and testing labs issued the weeks of April 7, 1 and 28, 2003. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number...

Untitled letters.(news briefs, bioresearch firms)
May 1, 2003... The following untitled letters were issued by the Division of Bioresearch Monitoring of the Center for Devices, Office of Compliance (CDRH-OC) in 2002. Copies of these letters are available to subscribers from RECORD-RETRIEVE for $7 plus...

IRB determination letters.
May 1, 2003... The following are Compliance Determination Letters for IRBs issued in March and April by the Department of Health and Human Services Office of Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to...