Bioresearch Monitoring Alert articles from October 2001

Bioresearch Monitoring Alert archives from October 2001

FDA not keeping pace with foreign BiMo audits, urged to inspect IRBs, push sponsors to do better monitoring.(Brief Article)
October 1, 2001... The number of non-U.S. clinical investigations under FDA purview has jumped 16-fold since 1990, but FDA bioresearch monitoring (BiMo) audits have increased only three fold during that time according to a new report by the Department of Health...

Part 11 validation requirements extended to Internet, OTS software.(Brief Article)
October 1, 2001... FDA Sept. 21 released a draft guidance on the validation requirements of the electronic signature/ records regulation (21 CFR Part 11), which recommends validating off-the-shelf (OTS) systems and even Internet communications, among other...

CBER's BiMo warning letters climb after gene therapy audits.(Brief Article)
October 1, 2001... As many would have expected, inspections and warning letters issued by FDA's Center for Biologics in fiscal 2001 for bioresearch monitoring issues were up 100%, largely because of increased oversight of gene therapy clinical trials. ...

Tektagen QA faults cited in visits two years apart.(Brief Article)
October 1, 2001... Tektagen, Inc., Malvern, PA, Philadelphia District Two visits two years apart found quality assurance violations at Tektagen, a control testing laboratory in Malvern, PA, all concerning reports of investigation of deviations in conducted...

Validation, documentation focus of GLP audits.(Brief Article)
October 1, 2001... BioAnalytika Labs, Durham, NC, Atlanta District; Huntingdon Life Science, East Millstone , NJ, New Jersey District; ViroMed, St. Paul, MN, Minneapolis District Validation and documentation are key interests of FDA inspectors in some GLP...

Investigator objects to definition of 'adverse event'.(Brief Article)
October 1, 2001... Robert Osher, M.D., Cincinnati Eye Institute, Cincinnati, OH, Cincinnati District Just what constitutes an "adverse event" that must be reported to FDA and others involved in clinical studies got a clinical research site in the practice of...

Investigator appears detached from his study's administration.(Brief Article)
October 1, 2001... Donald Johnson, M.D., Carolina Spine Institute, Mt. Pleasant, SC, Atlanta District An FDA inspector's report of her close-out discussion with a principal investigator indicated he was largely detached from the administration of the...

BiMo FOIA Log.(Brief Article)
October 1, 2001... 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...

CLARIFICATION.(Brief Article)
October 1, 2001... The BiMo Inspection Log in the Spring 2001 Premiere/Sample issue of BioResearch Monitoring Alert identifies individuals and organizations that have been the subject of a Freedom of Information Act (FOIA) request, not to an actual FDA...

NIDPOE Letters.(Brief Article)
October 1, 2001... The following "Notice of Initiation of Disqualifi-cation Proceedings and Opportunity to Explain" (NIDPOE) letter was issued by the CDRH Office of Compliance to the clinical investigator re-garding his conduct of clinical studies. This and other...

Warning Letters.(Brief Article)
October 1, 2001... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/ Monitors, CROs and testing labs, which were released since Sept. 1, 2001. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e.,...

IRB Determination Letters.(Brief Article)
October 1, 2001... The following are Compliance Determination Letters for IRBs issued in September by the National Institutes of Health Office for Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to these letters...