Bioresearch Monitoring Alert articles from September 2003

Bioresearch Monitoring Alert archives from September 2003

FDA may rewrite Part 11, but issues final guidance exempting 'legacy computers,' clarifies audit trails.(Electronic records)
September 1, 2003... FDA Sept. 3 issued a final guidance on how agency-regulated companies and sponsors should adhere to the 1997 electronic records/signature rule (21 CFR Part 11), but the guidance is only the beginning of an effort to rewrite the controversial...

BiMo auditors wary of documents, study results that 'look too good'.(Inspections)
September 1, 2003... FDAers who specialize in doing BiMo inspections are generally wary of possible fraud or misconduct if case report forms (CRFs), diary cards and other documents are too perfect or results of a study show few, or no, drop outs. Addressing a...

Patient safety bill faces Senate action; human subject protection bill not reintroduced.(Patient safety)
September 1, 2003... Congress appears to be moving toward adopting federal legislation, which President Bush is expected to sign, that would create a new confidential and voluntary system for reporting medical errors in an effort to reduce patient deaths. ...

Comments on proposed rule raise concern about who should file SADRs.(Safety reporting)
September 1, 2003... Two of the first comments submitted on the proposed regulation governing "Safety Reporting Requirements for Human Drugs and Biological Products" suggest FDA should not require a company to have a staff-based licensed M.D. to review post-market...

Firm escapes 483 despite numerous issues.(GLPs, Taylor Technology)
September 1, 2003... Taylor Technology, Princeton, NJ, New Jersey District District Although Taylor Technology Inc. (TTI) escaped a 483, a lengthy list of issues was uncovered by FDA's New Jersey District investigators Jean Kelahan and Nerizza Dalena. Those...

CRO lands 483 for missing electronic signature, improper password sharing.(CROs (contract research organizations), Perceptive Informatics)
September 1, 2003... Perceptive Informatics, Waltham, MA, New England District FDA's Sandra White of the New England District found numerous deficiencies during a June 2002 inspection of contract research organization (CRO) Perceptive Informatics, a division of...

FDA finds alleged misconduct charges well founded.(Clinical investigators)
September 1, 2003... Harry Bear, M.D., Virginia Commonwealth University, Richmond, VA, Baltimore District Serious and numerous deficiencies for failure to personally supervise or conduct a study, follow study protocol, obtain informed consent from all subjects...

Initial inspection nets CI six-item 483.(Clinical investigators)
September 1, 2003... Frederic Quitkin, M.D., New York State Psychiatric Institute, New York District Significant deficiencies, including informed consent documentation, subjects failing to meet inclusion criteria and failure to maintain complete records of...

483 cites CI for improper dosage times, lack of supervision; FDA later clears him on all citations.(Clinical investigators)
September 1, 2003... Donald Gleason, M.D., Advanced Clinical Therapeutics, Tucson, AZ, Los Angeles District Inadequate supervision and improper dosage times marked this high-priority CDER pre-approval inspection of Donald Gleason, M.D., conducted by Armando...

Warning letters.
September 1, 2003... The following is a recent FDA warning letter to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of July 14, 21 and 28; Aug. 4, 11, 18 and 25; and Sept. 1, 2003. Each letter is $7 plus retrieval. Please...

IRB determination letters.
September 1, 2003... The following are Compliance Determination Letters for IRBs issued in July and August 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...

BiMo FOIA log.
September 1, 2003... 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...