Bioresearch Monitoring Alert articles from December 2001

Bioresearch Monitoring Alert archives from December 2001

FDA not ready yet to have DMCs take control of adverse reports from IRBs.
December 1, 2001... BETHESDA, MD - Although the Inspector General (I.G.) of the Department of Health and Human Services recommended it in a landmark 1998 report on IRB failings to ensure human subject protection, FDA is not yet ready to have sponsor-financed...

GLP 483s down, but protocol deviations up, FDA enforcer says.
December 1, 2001... Failure to follow protocol is one of the most common problems uncovered in BiMo inspections, but Good Laboratory Practice (GLP) audits with problems are dropping, according to James McCormack Ph.D., BiMo program coordinator in the FDA Office...

High turnover of compliance officers tips off fraud probes, DOJ official says.
December 1, 2001... ANAHEIM, CA - High turnover of compliance officers in a research institution are often factors leading to probes of research fraud, a top-ranking Department of Justice (DOJ) official told a Health Care Compliance Assn. meeting here Nov. 29....

Penn trial death attributed to treating IRB as 'clerical'; more gene therapy guidance coming.
December 1, 2001... BALTIMORE - The University of Pennsylvania's BiMo run ins with FDA in the aftermath of the 1999 death of Jesse Gelsinger, a subject in a gene therapy trial, was partly blamed by a university official on how the institution's IRB was treated...

OHRP official asks IRBs to do self-reporting; quality program to launch.
December 1, 2001... BALTIMORE - OHRP is encouraging research institutions to self-report their own IRB and informed consent problems before the agency, itself, smells them out and next month will embark on "quality audits' of research sites. Elyse Summers,...

FDA gets non-compliance tip, cites CRO for deception, other serious violations.
December 1, 2001... Discovery Alliance (formerly d/b/a Gulf Coast Clinical Services), Mobile, AL, Nashville District In response to allegations that Gulf Coast Clinical Services, now known as Discovery Alliance, engaged in incidents of regulatory...

Lab comes through GLP, GMP inspections with set of 483s.(Covance Laboratories)
December 1, 2001... Covance Laboratories, Madison, WI, Minneapolis District A Covance laboratory facility in Madison, WI garnered a pair of 483s in GMP and GLP inspections that took place in the spring of 2000. The GMP inspection concluded March 10 and...

CI cited for some transgressions, gets by without 483.(Brief Article)
December 1, 2001... John Glaspy, M.D., Los Angeles, CA, Los Angeles District A clinical investigator/data audit inspection of John Glaspy, M.D., revealed a handful of deviations, but the investigator managed to avoid a 483. Antoine El-Hage and Gerald...

GLP inspection yields documentation lapses, SOP shortfalls.
December 1, 2001... Bristol-Myers Squibb, Syracuse, NY, New York District A GLP inspection of Bristol-Myers Squibb's Syracuse, NY, Drug Safety Evaluation Facility yielded a 483, revealing documentation problems and several inadequate SOPs, along with several...

BiMo FOIA Log.(Brief Article)
December 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...

Warning Letters.(Brief Article)
December 1, 2001... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors and CROs and testing labs released since Nov. 1, 2001. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e., 11052W...

IRB Determination Letters.
December 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...